{
  "@context": {
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    "@vocab": "https://schema.org/",
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    "occurred": "au:occurred",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1134-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP",
  "description": "FDA recall Z-1134-2025 — Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1134-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1134-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1134-2025: Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP",
      "text": "The FDA logged enforcement record Z-1134-2025: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP — reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-08. Affected lots/codes: 1)  CHIP99NC12, UDI-DI:10195594105471 (each) 50195594105479 (case),  Lot Number: J8692J         ; 2)  CHIP99NC13, UDI-DI:10195594202378 (each) 50195594202376 (case),  Lot Number: 5138245        ; 3)  CHIP99NC14, UDI-DI:10195594276898 (each) 50195594276896 (case),  Lot Number: 5324036        ; 4)  CHIP99NC15, UDI-DI:10195594399696 (each) 50195594399694 (case),  Lot Number: 5530905        ; 5)  CHIP99NC16, UDI-DI:10195594444846 (each) 50195594444844 (case),  Lot Number: 5530911        ; 6)  CHIP99NC17, UDI-DI:10197106046159 (each) 50197106046157 (case),  Lot Number: 6560930        ; 7)  CHIP99NC18, UDI-DI:10197106169643 (each) 50197106169641 (case),  Lot Number: 6701892        ; 8)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6264447        ; 9)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6986972        ; 10)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 7005424        ; 11)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J4218Z         ; 12)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J4678H         ; 13)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J4678T         ; 14)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J4950P         ; 15)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J53W06         ; 16)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: N/A            ; 17)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J6049N         ; 18)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J6365Y         ; 19)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J77Z27         ; 20)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J82M02         ; 21)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: N/A            ; 22)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J8393C         ; 23)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J84J89         ; 24)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: N/A            ; 25)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J6910P         ; 26)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J9602N         ; 27)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5664019        ; 28)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5664026        ; 29)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5891284        ; 30)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5631036        ; 31)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6022056        ; 32)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6264450        ; 33)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6345501        ; 34)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6563903        ; 35)  CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case),  Lot Number: 1055391        ; 36)  CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case),  Lot Number: 5138240        ; 37)  CHIP99NC23, UDI-DI:10195594229412 (each) 50195594229410 (case),  Lot Number: 5311235        ; 38)  CHIP99NC24, UDI-DI:10195594374297 (each) 50195594374295 (case),  Lot Number: 5138222        ; 39)  CHIP99NC25, UDI-DI:10195594416966 (each) 50195594416964 (case),  Lot Number: 5530901        ; 40)  CHIP99NC26, UDI-DI:10195594484736 (each) 50195594484734 (case),  Lot Number: 5631034        ; 41)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7332815        ; 42)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7280043        ; 43)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6264447        ; 44)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6905474        ; 45)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7058621        ; 46)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7005446        ; 47)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6701940        ; 48)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7055834        ; 49)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7260062        ; 50)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7260064        ; 51)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7280036        ; 52)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7280061        ; 53)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7160480        ; 54)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7260073        ; 55)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7331292        ; 56)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7331290        ; 57)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J4678H         ; 58)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J4679N         ; 59)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J4678W         ; 60)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: N/A            ; 61)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J5678T         ; 62)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J53W12         ; 63)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6049N         ; 64)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6049Y         ; 65)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J77Z26         ; 66)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J7904P         ; 67)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J82M03         ; 68)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J8491U         ; 69)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J84J86         ; 70)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: N/A            ; 71)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6365Z         ; 72)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J96N39         ; 73)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6365K         ; 74)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 5699520        ; 75)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 5699520        ; 76)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 5891286        ; 77)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6485583        ; 78)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6563907        ; 79)  CHIP99SP32, UDI-DI:10195594140274 (each) 50195594140272 (case),  Lot Number: 5138228        ; 80)  CHIP99SP33, UDI-DI:10195594229733 (each) 50195594229731 (case),  Lot Number: 5311233        ; 81)  CHIP99SP34, UDI-DI:10195594303280 (each) 50195594303288 (case),  Lot Number: 5372220        ; 82)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6022059        ; 83)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6905475        ; 84)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7005449        ; 85)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7055834        ; 86)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7122100        ; 87)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260057        ; 88)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260066        ; 89)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260068        ; 90)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260070        ; 91)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7280037        ; 92)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260072        ; 93)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7287459        ; 94)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7287469        ; 95)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6485591        ; 96)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7332810        ; 97)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J3986J         ; 98)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4678M         ; 99)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7332837        ; 100)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4679H         ; 101)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4950G         ; 102)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7360138        ; 103)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4950U         ; 104)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4951G         ; 105)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: N/A            ; 106)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J5678T         ; 107)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J8670H         ; 108)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J6785Z         ; 109)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J93M83         ; 110)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5405614        ; 111)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5631031        ; 112)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5664020        ; 113)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5699520        ; 114)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6022054        ; 115)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6345500        ; 116)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6563903        ; 117)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6563910        ; 118)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6701967        ; 119)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J4680A         ; 120)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J6049T         ; 121)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J6277P         ; 122)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J76N01         ; 123)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J7904R         ; 124)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J3986G         ; 125)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4678Z         ; 126)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4679C         ; 127)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4679G         ; 128)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4680C         ; 129)  PN11CNC10, UDI-DI:10195594392536 (each) 50195594392534 (case),  Lot Number: 5405610        ; 130)  PN11CNC11, UDI-DI:10195594511968 (each) 50195594511966 (case),  Lot Number: 5508042        ; 131)  PN11CNC12, UDI-DI:10195594565459 (each) 50195594565457 (case),  Lot Number: J6049X         ; 132)  PN11CNC13, UDI-DI:10195594610982 (each) 50195594610980 (case),  Lot Number: 5891282        ; 133)  PN11CNC14, UDI-DI:10195594774462 (each) 50195594774460 (case),  Lot Number: 6022061        ; 134)  PN11CNC15, UDI-DI:10195594808952 (each) 50195594808950 (case),  Lot Number: 6411398        ; 135)  PN11CNC16, UDI-DI:10197106329207 (each) 50197106329205 (case),  Lot Number: 7005438        ; 136)  PN11CNC17, UDI-DI:10197106448922 (each) 50197106448920 (case),  Lot Number: 7122100        ; 137)  PN11CNC18, UDI-DI:10197106529485 (each) 50197106529483 (case),  Lot Number: 7280036        ; 138)  PN11CNC19, UDI-DI:10197106646151 (each) 50197106646159 (case),  Lot Number: 7331285        ; 139)  PN11CNC20, UDI-DI:10197106800867 (each) 50197106800865 (case),  Lot Number: 7365538        ; 140)  PN11CNCH7, UDI-DI:10195594061531 (each) 50195594061539 (case),  Lot Number: 5136008        ; 141)  PN11CNCH8, UDI-DI:10195594126414 (each) 50195594126412 (case),  Lot Number: 5136036        ; 142)  PN11CNCH9, UDI-DI:10195594246341 (each) 50195594246349 (case),  Lot Number: 5138246        ; 143)  PN11CNCHN, UDI-DI:10888439472288 (each) 50888439472286 (case),  Lot Number: J3986G         ; 144)  PN11CNCHO, UDI-DI:10888439575491 (each) 50888439575499 (case),  Lot Number: J4678K         ; 145)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J4949Z         ; 146)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J4951A         ; 147)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J53W18         ; 148)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J6365X         ; 149)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J76N04         ; 150)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J82M03         ; 151)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J6365U         ; 152)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: J6910U         ; 153)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: J96A00         ; 154)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: 5530913        ; 155)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: 5631029        ; 156)  PN11CNCHS, UDI-DI:10195594494582 (each) 50195594494580 (case),  Lot Number: 5891291        ; 157)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6907768        ; 158)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6485580        ; 159)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6687084        ; 160)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6687083        ; 161)  PN11CNCHU, UDI-DI:10197106307496 (each) 50197106307494 (case),  Lot Number: 7260062        ; 162)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7287465        ; 163)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7331284        ; 164)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7331283        ; 165)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7331456        ; 166)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7332825        ; 167)  PN11NEXX2, UDI-DI:10195594290368 (each) 50195594290366 (case),  Lot Number: 5324047        ; 168)  PN11NEXX3, UDI-DI:10195594586072 (each) 50195594586070 (case),  Lot Number: 5664035        ; 169)  PN11NEXX4, UDI-DI:10197106006191 (each) 50197106006199 (case),  Lot Number: 6485583        ; 170)  PN11NEXX5, UDI-DI:10197106589069 (each) 50197106589067 (case),  Lot Number: 7287456        ; 171)  PN11NEXX6, UDI-DI:10197106714799 (each) 50197106714797 (case),  Lot Number: 7332807        ; 172)  PN11NEXX7, UDI-DI:10197106725498 (each) 50197106725496 (case),  Lot Number: 7332815        ; 173)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J6049W         ; 174)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J6277M         ; 175)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J76N03         ; 176)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J7962U         ; 177)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J8392Z         ; 178)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J90H78         ; 179)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J6786G         ; 180)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J70X16         ; 181)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5135980        ; 182)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5138245        ; 183)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5              ; 184)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5530889        ; 185)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5631031        ; 186)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6907761        ; 187)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7058621        ; 188)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7122004        ; 189)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6907748        ; 190)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7055836        ; 191)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7160474        ; 192)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7260069        ; 193)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7287472        ; 194)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6560923        ; 195)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: J6365M         ; 196)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 5891296        ; 197)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6022052        ; 198)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6264450        ; 199)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6687061        ; 200)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6687082        ; 201)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6701945        ; 202)  PN11OTR10, UDI-DI:10197106121214 (each) 50197106121212 (case),  Lot Number: 6560956        ; 203)  PN11OTR11, UDI-DI:10197106238080 (each) 50197106238088 (case),  Lot Number: 6702040        ; 204)  PN11OTR12, UDI-DI:10197106342343 (each) 50197106342341 (case),  Lot Number: 6702040        ; 205)  PN11OTR13, UDI-DI:10197106419526 (each) 50197106419524 (case),  Lot Number: 6806122        ; 206)  PN11OTR14, UDI-DI:10197106560525 (each) 50197106560523 (case),  Lot Number: 7287574        ; 207)  PN11OTRM1, UDI-DI:10195594004057 (each) 50195594004055 (case),  Lot Number: J8998R         ; 208)  PN11OTRM2, UDI-DI:10195594177089 (each) 50195594177087 (case),  Lot Number: 5140388        ; 209)  PN11OTRM3, UDI-DI:10195594276294 (each) 50195594276292 (case),  Lot Number: 5140390        ; 210)  PN11OTRM4, UDI-DI:10195594412296 (each) 50195594412294 (case),  Lot Number: 5533344        ; 211)  PN11OTRM5, UDI-DI:10195594494964 (each) 50195594494962 (case),  Lot Number: J65K19         ; 212)  PN11OTRM7, UDI-DI:10195594687755 (each) 50195594687753 (case),  Lot Number: 5918342        ; 213)  PN11OTRM8, UDI-DI:10195594758905 (each) 50195594758903 (case),  Lot Number: 6251073        ; 214)  PN11OTRM9, UDI-DI:10197106055694 (each) 50197106055692 (case),  Lot Number: 6345528        ; 215)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J3593P         ; 216)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4220C         ; 217)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J43W15         ; 218)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J46C10         ; 219)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4953C         ; 220)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4953F         ; 221)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J6022K         ; 222)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J6022K         ; 223)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J6373A         ; 224)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J7708T         ; 225)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J79Z50         ; 226)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4953F         ; 227)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J79Z51         ; 228)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J87C82         ; 229)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J8998R         ; 230)  PN11OTRMR, UDI-DI:10195594238391 (each) 50195594238399 (case),  Lot Number: 5858469        ; 231)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6251078        ; 232)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6251076        ; 233)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6345528        ; 234)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6560956        ; 235)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7160540        ; 236)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7160540        ; 237)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7287574        ; 238)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7163125        ; 239)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7287580        ; 240)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7331480        ; 241)  PN11OTRMW, UDI-DI:10197106653715 (each) 50197106653713 (case),  Lot Number: 7333447        ; 242)  PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case),  Lot Number: J4680D         ; 243)  PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case),  Lot Number: J4950P         ; 244)  PN11SHCH6, UDI-DI:10888439799217 (each) 50888439799215 (case),  Lot Number: J6277R         ; 245)  PN11SHCH7, UDI-DI:10888439845044 (each) 50888439845042 (case),  Lot Number: J74A18         ; 246)  PN11SHCHQ, UDI-DI:10888439472011 (each) 50888439472019 (case),  Lot Number: J4219A         ; 247)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4679X         ; 248)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4679Z         ; 249)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4680H         ; 250)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4950H         ; 251)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J74A18         ; 252)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J82K97         ; 253)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J8123N         ; 254)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J82K96         ; 255)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J6365U         ; 256)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J6910U         ; 257)  PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case),  Lot Number: 6701948        ; 258)  PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case),  Lot Number: 6470296        ; 259)  PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case),  Lot Number: 6560949        ; 260)  PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case),  Lot Number: 6907770        ; 261)  PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case),  Lot Number: 6748354        ; 262)  PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case),  Lot Number: 6788668        ; 263)  PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case),  Lot Number: 7280050        ; 264)  PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case),  Lot Number: 7332858        ; 265)  PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case),  Lot Number: 7269982        ; 266)  PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case),  Lot Number: 6560923        ; 267)  PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case),  Lot Number: 7331313        ; 268)  PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case),  Lot Number: 7365541        ; 269)  PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case),  Lot Number: 7332814        ; 270)  PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case),  Lot Number: 7331319        ; 271)  PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case),  Lot Number: 7332923        ; 272)  PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case),  Lot Number: 7102720        ; 273)  PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case),  Lot Number: 7332876        ; 274)  PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case),  Lot Number: 7163123        ; 275)  PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case),  Lot Number: J9602R         ; 276)  PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case),  Lot Number: J8045P         ; 277)  PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case),  Lot Number: J9197H         ; 278)  PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case),  Lot Number: 5136036        ; 279)  PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case),  Lot Number: 5136012        ; 280)  PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case),  Lot Number: J9850D         ; 281)  PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case),  Lot Number: 5311242        ; 282)  PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case),  Lot Number: J9699Y         ; 283)  PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case),  Lot Number: 5140379        ; 284)  PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case),  Lot Number: 5324040        ; 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296)  PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case),  Lot Number: 6563903        ; 297)  PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case),  Lot Number: 6416680        ; 298)  PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case),  Lot Number: 6345527        ; 299)  PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case),  Lot Number: 6687061        ; 300)  PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case),  Lot Number: 6416681        ; 301)  PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case),  Lot Number: 6487917        ; 302)  PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case),  Lot Number: 5891284        ; 303)  PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case),  Lot Number: 5891299        ; 304)  PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case),  Lot Number: 5858465        ; 305)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6701937        ; 306)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6701850        ; 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318)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5891292        ; 319)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5891299        ; 320)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5664106        ; 321)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6022055        ; 322)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6232004        ; 323)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6025794        ; 324)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6183268        ; 325)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6345511        ; 326)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6025793        ; 327)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5530907        ; 328)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6416678        ; 329)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6487906        ; 330)  PN15LSRME, UDI-DI:10197106409206 (each. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1134-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1134-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1134-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1134-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1134-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1134-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1134-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1134-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1134-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Cardinal Health 200, LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-08",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
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22)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J8393C         ; 23)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J84J89         ; 24)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: N/A            ; 25)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J6910P         ; 26)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: J9602N         ; 27)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5664019        ; 28)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5664026        ; 29)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5891284        ; 30)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 5631036        ; 31)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6022056        ; 32)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6264450        ; 33)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6345501        ; 34)  CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case),  Lot Number: 6563903        ; 35)  CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case),  Lot Number: 1055391        ; 36)  CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case),  Lot Number: 5138240        ; 37)  CHIP99NC23, UDI-DI:10195594229412 (each) 50195594229410 (case),  Lot Number: 5311235        ; 38)  CHIP99NC24, UDI-DI:10195594374297 (each) 50195594374295 (case),  Lot Number: 5138222        ; 39)  CHIP99NC25, UDI-DI:10195594416966 (each) 50195594416964 (case),  Lot Number: 5530901        ; 40)  CHIP99NC26, UDI-DI:10195594484736 (each) 50195594484734 (case),  Lot Number: 5631034        ; 41)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7332815        ; 42)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7280043        ; 43)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6264447        ; 44)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6905474        ; 45)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7058621        ; 46)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7005446        ; 47)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6701940        ; 48)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7055834        ; 49)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7260062        ; 50)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7260064        ; 51)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7280036        ; 52)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7280061        ; 53)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7160480        ; 54)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7260073        ; 55)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7331292        ; 56)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 7331290        ; 57)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J4678H         ; 58)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J4679N         ; 59)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J4678W         ; 60)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: N/A            ; 61)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J5678T         ; 62)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J53W12         ; 63)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6049N         ; 64)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6049Y         ; 65)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J77Z26         ; 66)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J7904P         ; 67)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J82M03         ; 68)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J8491U         ; 69)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J84J86         ; 70)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: N/A            ; 71)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6365Z         ; 72)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J96N39         ; 73)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: J6365K         ; 74)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 5699520        ; 75)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 5699520        ; 76)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 5891286        ; 77)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6485583        ; 78)  CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case),  Lot Number: 6563907        ; 79)  CHIP99SP32, UDI-DI:10195594140274 (each) 50195594140272 (case),  Lot Number: 5138228        ; 80)  CHIP99SP33, UDI-DI:10195594229733 (each) 50195594229731 (case),  Lot Number: 5311233        ; 81)  CHIP99SP34, UDI-DI:10195594303280 (each) 50195594303288 (case),  Lot Number: 5372220        ; 82)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6022059        ; 83)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6905475        ; 84)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7005449        ; 85)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7055834        ; 86)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7122100        ; 87)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260057        ; 88)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260066        ; 89)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260068        ; 90)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260070        ; 91)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7280037        ; 92)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7260072        ; 93)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7287459        ; 94)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7287469        ; 95)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6485591        ; 96)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7332810        ; 97)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J3986J         ; 98)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4678M         ; 99)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7332837        ; 100)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4679H         ; 101)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4950G         ; 102)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 7360138        ; 103)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4950U         ; 104)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J4951G         ; 105)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: N/A            ; 106)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J5678T         ; 107)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J8670H         ; 108)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J6785Z         ; 109)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: J93M83         ; 110)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5405614        ; 111)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5631031        ; 112)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5664020        ; 113)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 5699520        ; 114)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6022054        ; 115)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6345500        ; 116)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6563903        ; 117)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6563910        ; 118)  CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case),  Lot Number: 6701967        ; 119)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J4680A         ; 120)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J6049T         ; 121)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J6277P         ; 122)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J76N01         ; 123)  P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case),  Lot Number: J7904R         ; 124)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J3986G         ; 125)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4678Z         ; 126)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4679C         ; 127)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4679G         ; 128)  PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case),  Lot Number: J4680C         ; 129)  PN11CNC10, UDI-DI:10195594392536 (each) 50195594392534 (case),  Lot Number: 5405610        ; 130)  PN11CNC11, UDI-DI:10195594511968 (each) 50195594511966 (case),  Lot Number: 5508042        ; 131)  PN11CNC12, UDI-DI:10195594565459 (each) 50195594565457 (case),  Lot Number: J6049X         ; 132)  PN11CNC13, UDI-DI:10195594610982 (each) 50195594610980 (case),  Lot Number: 5891282        ; 133)  PN11CNC14, UDI-DI:10195594774462 (each) 50195594774460 (case),  Lot Number: 6022061        ; 134)  PN11CNC15, UDI-DI:10195594808952 (each) 50195594808950 (case),  Lot Number: 6411398        ; 135)  PN11CNC16, UDI-DI:10197106329207 (each) 50197106329205 (case),  Lot Number: 7005438        ; 136)  PN11CNC17, UDI-DI:10197106448922 (each) 50197106448920 (case),  Lot Number: 7122100        ; 137)  PN11CNC18, UDI-DI:10197106529485 (each) 50197106529483 (case),  Lot Number: 7280036        ; 138)  PN11CNC19, UDI-DI:10197106646151 (each) 50197106646159 (case),  Lot Number: 7331285        ; 139)  PN11CNC20, UDI-DI:10197106800867 (each) 50197106800865 (case),  Lot Number: 7365538        ; 140)  PN11CNCH7, UDI-DI:10195594061531 (each) 50195594061539 (case),  Lot Number: 5136008        ; 141)  PN11CNCH8, UDI-DI:10195594126414 (each) 50195594126412 (case),  Lot Number: 5136036        ; 142)  PN11CNCH9, UDI-DI:10195594246341 (each) 50195594246349 (case),  Lot Number: 5138246        ; 143)  PN11CNCHN, UDI-DI:10888439472288 (each) 50888439472286 (case),  Lot Number: J3986G         ; 144)  PN11CNCHO, UDI-DI:10888439575491 (each) 50888439575499 (case),  Lot Number: J4678K         ; 145)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J4949Z         ; 146)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J4951A         ; 147)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J53W18         ; 148)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J6365X         ; 149)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J76N04         ; 150)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J82M03         ; 151)  PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case),  Lot Number: J6365U         ; 152)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: J6910U         ; 153)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: J96A00         ; 154)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: 5530913        ; 155)  PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case),  Lot Number: 5631029        ; 156)  PN11CNCHS, UDI-DI:10195594494582 (each) 50195594494580 (case),  Lot Number: 5891291        ; 157)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6907768        ; 158)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6485580        ; 159)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6687084        ; 160)  PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case),  Lot Number: 6687083        ; 161)  PN11CNCHU, UDI-DI:10197106307496 (each) 50197106307494 (case),  Lot Number: 7260062        ; 162)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7287465        ; 163)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7331284        ; 164)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7331283        ; 165)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7331456        ; 166)  PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case),  Lot Number: 7332825        ; 167)  PN11NEXX2, UDI-DI:10195594290368 (each) 50195594290366 (case),  Lot Number: 5324047        ; 168)  PN11NEXX3, UDI-DI:10195594586072 (each) 50195594586070 (case),  Lot Number: 5664035        ; 169)  PN11NEXX4, UDI-DI:10197106006191 (each) 50197106006199 (case),  Lot Number: 6485583        ; 170)  PN11NEXX5, UDI-DI:10197106589069 (each) 50197106589067 (case),  Lot Number: 7287456        ; 171)  PN11NEXX6, UDI-DI:10197106714799 (each) 50197106714797 (case),  Lot Number: 7332807        ; 172)  PN11NEXX7, UDI-DI:10197106725498 (each) 50197106725496 (case),  Lot Number: 7332815        ; 173)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J6049W         ; 174)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J6277M         ; 175)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J76N03         ; 176)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J7962U         ; 177)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J8392Z         ; 178)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J90H78         ; 179)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J6786G         ; 180)  PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case),  Lot Number: J70X16         ; 181)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5135980        ; 182)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5138245        ; 183)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5              ; 184)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5530889        ; 185)  PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case),  Lot Number: 5631031        ; 186)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6907761        ; 187)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7058621        ; 188)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7122004        ; 189)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6907748        ; 190)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7055836        ; 191)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7160474        ; 192)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7260069        ; 193)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 7287472        ; 194)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6560923        ; 195)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: J6365M         ; 196)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 5891296        ; 197)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6022052        ; 198)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6264450        ; 199)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6687061        ; 200)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6687082        ; 201)  PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case),  Lot Number: 6701945        ; 202)  PN11OTR10, UDI-DI:10197106121214 (each) 50197106121212 (case),  Lot Number: 6560956        ; 203)  PN11OTR11, UDI-DI:10197106238080 (each) 50197106238088 (case),  Lot Number: 6702040        ; 204)  PN11OTR12, UDI-DI:10197106342343 (each) 50197106342341 (case),  Lot Number: 6702040        ; 205)  PN11OTR13, UDI-DI:10197106419526 (each) 50197106419524 (case),  Lot Number: 6806122        ; 206)  PN11OTR14, UDI-DI:10197106560525 (each) 50197106560523 (case),  Lot Number: 7287574        ; 207)  PN11OTRM1, UDI-DI:10195594004057 (each) 50195594004055 (case),  Lot Number: J8998R         ; 208)  PN11OTRM2, UDI-DI:10195594177089 (each) 50195594177087 (case),  Lot Number: 5140388        ; 209)  PN11OTRM3, UDI-DI:10195594276294 (each) 50195594276292 (case),  Lot Number: 5140390        ; 210)  PN11OTRM4, UDI-DI:10195594412296 (each) 50195594412294 (case),  Lot Number: 5533344        ; 211)  PN11OTRM5, UDI-DI:10195594494964 (each) 50195594494962 (case),  Lot Number: J65K19         ; 212)  PN11OTRM7, UDI-DI:10195594687755 (each) 50195594687753 (case),  Lot Number: 5918342        ; 213)  PN11OTRM8, UDI-DI:10195594758905 (each) 50195594758903 (case),  Lot Number: 6251073        ; 214)  PN11OTRM9, UDI-DI:10197106055694 (each) 50197106055692 (case),  Lot Number: 6345528        ; 215)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J3593P         ; 216)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4220C         ; 217)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J43W15         ; 218)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J46C10         ; 219)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4953C         ; 220)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4953F         ; 221)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J6022K         ; 222)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J6022K         ; 223)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J6373A         ; 224)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J7708T         ; 225)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J79Z50         ; 226)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J4953F         ; 227)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J79Z51         ; 228)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J87C82         ; 229)  PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case),  Lot Number: J8998R         ; 230)  PN11OTRMR, UDI-DI:10195594238391 (each) 50195594238399 (case),  Lot Number: 5858469        ; 231)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6251078        ; 232)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6251076        ; 233)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6345528        ; 234)  PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case),  Lot Number: 6560956        ; 235)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7160540        ; 236)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7160540        ; 237)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7287574        ; 238)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7163125        ; 239)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7287580        ; 240)  PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case),  Lot Number: 7331480        ; 241)  PN11OTRMW, UDI-DI:10197106653715 (each) 50197106653713 (case),  Lot Number: 7333447        ; 242)  PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case),  Lot Number: J4680D         ; 243)  PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case),  Lot Number: J4950P         ; 244)  PN11SHCH6, UDI-DI:10888439799217 (each) 50888439799215 (case),  Lot Number: J6277R         ; 245)  PN11SHCH7, UDI-DI:10888439845044 (each) 50888439845042 (case),  Lot Number: J74A18         ; 246)  PN11SHCHQ, UDI-DI:10888439472011 (each) 50888439472019 (case),  Lot Number: J4219A         ; 247)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4679X         ; 248)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4679Z         ; 249)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4680H         ; 250)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J4950H         ; 251)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J74A18         ; 252)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J82K97         ; 253)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J8123N         ; 254)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J82K96         ; 255)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J6365U         ; 256)  PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case),  Lot Number: J6910U         ; 257)  PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case),  Lot Number: 6701948        ; 258)  PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case),  Lot Number: 6470296        ; 259)  PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case),  Lot Number: 6560949        ; 260)  PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case),  Lot Number: 6907770        ; 261)  PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case),  Lot Number: 6748354        ; 262)  PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case),  Lot Number: 6788668        ; 263)  PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case),  Lot Number: 7280050        ; 264)  PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case),  Lot Number: 7332858        ; 265)  PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case),  Lot Number: 7269982        ; 266)  PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case),  Lot Number: 6560923        ; 267)  PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case),  Lot Number: 7331313        ; 268)  PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case),  Lot Number: 7365541        ; 269)  PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case),  Lot Number: 7332814        ; 270)  PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case),  Lot Number: 7331319        ; 271)  PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case),  Lot Number: 7332923        ; 272)  PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case),  Lot Number: 7102720        ; 273)  PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case),  Lot Number: 7332876        ; 274)  PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case),  Lot Number: 7163123        ; 275)  PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case),  Lot Number: J9602R         ; 276)  PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case),  Lot Number: J8045P         ; 277)  PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case),  Lot Number: J9197H         ; 278)  PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case),  Lot Number: 5136036        ; 279)  PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case),  Lot Number: 5136012        ; 280)  PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case),  Lot Number: J9850D         ; 281)  PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case),  Lot Number: 5311242        ; 282)  PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case),  Lot Number: J9699Y         ; 283)  PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case),  Lot Number: 5140379        ; 284)  PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case),  Lot Number: 5324040        ; 285)  PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case),  Lot Number: 5405620        ; 286)  PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case),  Lot Number: 5140385        ; 287)  PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case),  Lot Number: 5405614        ; 288)  PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case),  Lot Number: 5138334        ; 289)  PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case),  Lot Number: 5533338        ; 290)  PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case),  Lot Number: 5631025        ; 291)  PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case),  Lot Number: 5631060        ; 292)  PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case),  Lot Number: 5478805        ; 293)  PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case),  Lot Number: J53W15         ; 294)  PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case),  Lot Number: 5508051        ; 295)  PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case),  Lot Number: 5664107        ; 296)  PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case),  Lot Number: 6563903        ; 297)  PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case),  Lot Number: 6416680        ; 298)  PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case),  Lot Number: 6345527        ; 299)  PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case),  Lot Number: 6687061        ; 300)  PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case),  Lot Number: 6416681        ; 301)  PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case),  Lot Number: 6487917        ; 302)  PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case),  Lot Number: 5891284        ; 303)  PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case),  Lot Number: 5891299        ; 304)  PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case),  Lot Number: 5858465        ; 305)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6701937        ; 306)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6701850        ; 307)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6702035        ; 308)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 7005434        ; 309)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 7005438        ; 310)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6748356        ; 311)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6779959        ; 312)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 7005433        ; 313)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6775067        ; 314)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 7160529        ; 315)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5664021        ; 316)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5891300        ; 317)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5970336        ; 318)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5891292        ; 319)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5891299        ; 320)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5664106        ; 321)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6022055        ; 322)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6232004        ; 323)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6025794        ; 324)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6183268        ; 325)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6345511        ; 326)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6025793        ; 327)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 5530907        ; 328)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6416678        ; 329)  PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case),  Lot Number: 6487906        ; 330)  PN15LSRME, UDI-DI:10197106409206 (each",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}