{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
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    "grounding": "au:grounding",
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    "sourceUrl": "au:sourceUrl",
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    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0915-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Cardinal Health Presource Kits: 1)  CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2)  CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10)  KIT, CRANIOTOMY PMH  , Catalog Number: PN08CPPCA; 11)  KIT, NEURO  , Catalog Number: PN11NEXX1; 12)  KIT, NEURO  , Catalog Number: PN11NEXXA; 13)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW2; 14)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW3; 15)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWG; 16)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWH; 17)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG1; 18)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG2; 19)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG3; 20)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG4; 21)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG5; 22)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEGA; 23)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH2; 27)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH3; 28)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH4; 29)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH5; 30)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH6; 31)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH7; 32)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAHA; 33)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY734; 37)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY735; 38)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73D; 40)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73F; 41)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73G; 42)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73H; 43)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46)  KIT,CRANIOTOMY,ANDERSON   , Catalog Number: PN23CYAMY; 47)  KIT,LAMINECTOMY  RF  , Catalog Number: PN23LMCVU; 48)  KIT, NEURO  , Catalog Number: PN23NKME1; 49)  KIT, NEURO  , Catalog Number: PN23NKMEA; 50)  KIT, NEURO  , Catalog Number: PN23NKMEB; 51)  KIT, NEURO  , Catalog Number: PN23NKMEC; 52)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA10; 53)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA11; 54)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA12; 55)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA13; 56)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM3; 57)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM4; 58)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM6; 59)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM7; 60)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM8; 61)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM9; 62)  NEURO SPINE,ANDERSON,KIT  , Catalog Number: PN23SPAMS; 63)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMV; 64)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMW; 65)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMX; 66)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMY; 67)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA10; 68)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA11; 69)  KIT, CR",
  "description": "FDA recall Z-0915-2025 — Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1)  CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2)  CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10)  KIT, CRANIOTOMY PMH  , Catalog Number: PN08CPPCA; 11)  KIT, NEURO  , Catalog Number: PN11NEXX1; 12)  KIT, NEURO  , Catalog Number: PN11NEXXA; 13)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW2; 14)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW3; 15)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWG; 16)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWH; 17)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG1; 18)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG2; 19)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG3; 20)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG4; 21)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG5; 22)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEGA; 23)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH2; 27)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH3; 28)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH4; 29)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH5; 30)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH6; 31)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH7; 32)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAHA; 33)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY734; 37)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY735; 38)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73D; 40)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73F; 41)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73G; 42)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73H; 43)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46)  KIT,CRANIOTOMY,ANDERSON   , Catalog Number: PN23CYAMY; 47)  KIT,LAMINECTOMY  RF  , Catalog Number: PN23LMCVU; 48)  KIT, NEURO  , Catalog Number: PN23NKME1; 49)  KIT, NEURO  , Catalog Number: PN23NKMEA; 50)  KIT, NEURO  , Catalog Number: PN23NKMEB; 51)  KIT, NEURO  , Catalog Number: PN23NKMEC; 52)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA10; 53)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA11; 54)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA12; 55)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA13; 56)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM3; 57)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM4; 58)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM6; 59)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM7; 60)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM8; 61)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM9; 62)  NEURO SPINE,ANDERSON,KIT  , Catalog Number: PN23SPAMS; 63)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMV; 64)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMW; 65)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMX; 66)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMY; 67)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA10; 68)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA11; 69)  KIT, CR (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-0915-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Cardinal Health Presource Kits: 1)  CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2)  CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10)  KIT, CRANIOTOMY PMH  , Catalog Number: PN08CPPCA; 11)  KIT, NEURO  , Catalog Number: PN11NEXX1; 12)  KIT, NEURO  , Catalog Number: PN11NEXXA; 13)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW2; 14)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW3; 15)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWG; 16)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWH; 17)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG1; 18)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG2; 19)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG3; 20)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG4; 21)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG5; 22)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEGA; 23)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH2; 27)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH3; 28)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH4; 29)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH5; 30)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH6; 31)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH7; 32)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAHA; 33)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY734; 37)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY735; 38)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73D; 40)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73F; 41)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73G; 42)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73H; 43)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46)  KIT,CRANIOTOMY,ANDERSON   , Catalog Number: PN23CYAMY; 47)  KIT,LAMINECTOMY  RF  , Catalog Number: PN23LMCVU; 48)  KIT, NEURO  , Catalog Number: PN23NKME1; 49)  KIT, NEURO  , Catalog Number: PN23NKMEA; 50)  KIT, NEURO  , Catalog Number: PN23NKMEB; 51)  KIT, NEURO  , Catalog Number: PN23NKMEC; 52)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA10; 53)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA11; 54)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA12; 55)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA13; 56)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM3; 57)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM4; 58)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM6; 59)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM7; 60)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM8; 61)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM9; 62)  NEURO SPINE,ANDERSON,KIT  , Catalog Number: PN23SPAMS; 63)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMV; 64)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMW; 65)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMX; 66)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMY; 67)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA10; 68)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA11; 69)  KIT, CR",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0915-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0915-2025: Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1)  CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2)  CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10)  KIT, CRANIOTOMY PMH  , Catalog Number: PN08CPPCA; 11)  KIT, NEURO  , Catalog Number: PN11NEXX1; 12)  KIT, NEURO  , Catalog Number: PN11NEXXA; 13)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW2; 14)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW3; 15)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWG; 16)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWH; 17)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG1; 18)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG2; 19)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG3; 20)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG4; 21)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG5; 22)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEGA; 23)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH2; 27)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH3; 28)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH4; 29)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH5; 30)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH6; 31)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH7; 32)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAHA; 33)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY734; 37)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY735; 38)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73D; 40)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73F; 41)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73G; 42)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73H; 43)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46)  KIT,CRANIOTOMY,ANDERSON   , Catalog Number: PN23CYAMY; 47)  KIT,LAMINECTOMY  RF  , Catalog Number: PN23LMCVU; 48)  KIT, NEURO  , Catalog Number: PN23NKME1; 49)  KIT, NEURO  , Catalog Number: PN23NKMEA; 50)  KIT, NEURO  , Catalog Number: PN23NKMEB; 51)  KIT, NEURO  , Catalog Number: PN23NKMEC; 52)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA10; 53)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA11; 54)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA12; 55)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA13; 56)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM3; 57)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM4; 58)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM6; 59)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM7; 60)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM8; 61)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM9; 62)  NEURO SPINE,ANDERSON,KIT  , Catalog Number: PN23SPAMS; 63)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMV; 64)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMW; 65)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMX; 66)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMY; 67)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA10; 68)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA11; 69)  KIT, CR",
      "text": "The FDA logged enforcement record Z-0915-2025: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Presource Kits: 1)  CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2)  CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10)  KIT, CRANIOTOMY PMH  , Catalog Number: PN08CPPCA; 11)  KIT, NEURO  , Catalog Number: PN11NEXX1; 12)  KIT, NEURO  , Catalog Number: PN11NEXXA; 13)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW2; 14)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW3; 15)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWG; 16)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWH; 17)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG1; 18)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG2; 19)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG3; 20)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG4; 21)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEG5; 22)  KIT, MAJOR NEURO     , Catalog Number: PN21MNEGA; 23)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25)  KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH2; 27)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH3; 28)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH4; 29)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH5; 30)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH6; 31)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAH7; 32)  KIT,CRANIOTOMY   , Catalog Number: PN23CFAHA; 33)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY734; 37)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY735; 38)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73D; 40)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73F; 41)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73G; 42)  KIT ,CRANIOTOMY ANDERSON  , Catalog Number: PN23CY73H; 43)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45)  KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46)  KIT,CRANIOTOMY,ANDERSON   , Catalog Number: PN23CYAMY; 47)  KIT,LAMINECTOMY  RF  , Catalog Number: PN23LMCVU; 48)  KIT, NEURO  , Catalog Number: PN23NKME1; 49)  KIT, NEURO  , Catalog Number: PN23NKMEA; 50)  KIT, NEURO  , Catalog Number: PN23NKMEB; 51)  KIT, NEURO  , Catalog Number: PN23NKMEC; 52)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA10; 53)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA11; 54)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA12; 55)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPA13; 56)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM3; 57)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM4; 58)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM6; 59)  KIT,NEURO SPINE,ANDERSON  , Catalog Number: PN23SPAM7; 60)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM8; 61)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAM9; 62)  NEURO SPINE,ANDERSON,KIT  , Catalog Number: PN23SPAMS; 63)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMV; 64)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMW; 65)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMX; 66)  KIT, NEURO SPINE, ANDERSON     , Catalog Number: PN23SPAMY; 67)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA10; 68)  KIT, CRANIOTOMY  , Catalog Number: PN29CRA11; 69)  KIT, CR — reason: Potential 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: Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number  5631070        ;  Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number  5530905        ;  Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number  5138271        ;  Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number  5533340        ;  Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number  5136018        ;  Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number  5136034        ;  Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number  5136012        ;  Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number  5136019        ;  Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number  5140342        ;  Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number  5324034        ;  Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number  5138327        ;  Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number  5140378        ;  Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number  5478803        ;  Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number  5324048        ;  Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number  5138335        ;  Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number  5405629        ;  Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number  5478804        ;  Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number  5138222        ;  Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number  5138325        ;  Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number  5405629        ;  Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number  6701852        ;  Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number  6905475        ;  Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number  6748352        ;  Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number  6702036        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6788561        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6928764        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7163104        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7331341        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6928772        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7332910        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J3464F         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J34J41         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J37U06         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J43U77         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4952D         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679H         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J6050D         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J74A27         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679M         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7963H         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J8123Z         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J86T82         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631072        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631073        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5891310        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6025785        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6169297        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6345524        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6563988        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6907762        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6987090        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6806116        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7260066        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7163081        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7280113        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7260073        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7287536        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7331351        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7331283        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7331323        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7331347        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7287463        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7332858        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7269982        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7348991        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7331474        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  7280114        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4219A         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J37T95         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J30T06         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4219D         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J3986R         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J37U14         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4678Z         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4219W         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J37U14         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4679H         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4877D         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J332169        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J46C05         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4951F         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4877T         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4952R         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J6049Y         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J65K13         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679P         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J68T51         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J6786P         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679T         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J74A12         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J74A02         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679T         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J53W20         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J76N08         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7704J         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7962U         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J8045W         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7905H         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J8491U         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J8064U         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7905J         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J84K06         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J70X14         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J70X08         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J6368X         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631031        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5533309        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5533341        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631044        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631062        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5664105        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5891284        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5891301        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5565995        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6345502        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6133659        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6264573        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6485584        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6364783        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6487906        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6560930        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6498134        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6487916        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6563915        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  202202103      ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6568673        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6702024        ;  Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number  J53W69         ;  Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number  J53W09         ;  Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number  J5678H         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J22M91         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J43U77         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J46C04         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J53W73         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J72P53         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J74A28         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8064Y         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8064Z         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8123Z         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8393U         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J43U62         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J37U05         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J4950H         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J46A95         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J4951G         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J53W54         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J53W20         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J5678J         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J74A17         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J5678J         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J74A18         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H50         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J82M03         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H48         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H49         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H50         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8670H         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8393H         ;  Catalog Number PN08CPPCA, UDI/DI 10197106722909 (EA)50197106722907 (CS), Lot Number  7331310        ;  Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number  J46C04         ;  Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number  J4680A         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J30T39         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J53W72         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J4949U         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J53W13         ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  18J2583        ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  J4952C         ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  J4680A         ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  J4952P         ;  Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number  J6367F         ;  Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number  5138222        ;  Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number  5533338        ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  18B0346        ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J3464G         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  19E1526        ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J53W67         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J37T59         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J30T08         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J6277M         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J5679N         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  19L3475        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J5679H         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  19L3475        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J84K01         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  19L3475        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J84K02         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  5478803        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J82M01         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J7963U         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J82M01         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J7964A         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J8491U         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J85W30         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  5324047        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  5405629        ;  Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number  5140356        ;  Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number  5138244        ;  Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number  5478803        ;  Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number  5324034        ;  Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number  J6278U         ;  Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number  5324040        ;  Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number  5970334        ;  Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number  6022053        ;  Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number  6025786        ;  Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number  6022060        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6563989        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6563988        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6788561        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928762        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928766        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928764        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7280110        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7287567        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332904        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332909        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928772        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J8123Z         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J84K02         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J86T83         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5533336        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5618932        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J6278U         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5664100        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5876883        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5888374        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6022130        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6345523        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6264447        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6986974        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7122004        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7260053        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7286184        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7260068        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7280048        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7287483        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7331285        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332804        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332837        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J8393A         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J8491U         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J6366D         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5508039        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5530912        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  531025         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5508041        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J6277T         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6485589        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6687082        ;  Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number  18H2278        ;  Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number  J46C03         ;  Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number  J5678M         ;  Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number  18M3535        ;  Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number  J6050D         ;  Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number  J6365Y         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  18H2205        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J37U06         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  18H2278        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J46A97         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  18H2278        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J22M99         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  19A0124        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J4952M         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J3986K         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J4679C         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J4950G         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J53W13         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J30T25         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J3987C         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J4678K         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J4219Z         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J46A89         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J37U13         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J4219N         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J43U77         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J4679P         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J43U77         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J46A91         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J46C06         ;  Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number  J46A88         ;  Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number  J46A98         ; 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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-0915-2025&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-0915-2025&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-0915-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0915-2025 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-0915-2025&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-0915-2025&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-0915-2025/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."
    }
  ],
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      "name": "FDA recall details — Z-0915-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0915-2025",
            "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 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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 Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4219D         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J3986R         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J37U14         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4678Z         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4219W         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J37U14         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4679H         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4877D         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J332169        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J46C05         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4951F         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4877T         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J4952R         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J6049Y         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J65K13         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679P         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J68T51         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J6786P         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679T         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J74A12         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J74A02         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J5679T         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J53W20         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J76N08         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7704J         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7962U         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J8045W         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7905H         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J8491U         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J8064U         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J7905J         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J84K06         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J70X14         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J70X08         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  J6368X         ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631031        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5533309        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5533341        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631044        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5631062        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5664105        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5891284        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5891301        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  5565995        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6345502        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6133659        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6264573        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6485584        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6364783        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6487906        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6560930        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6498134        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6487916        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6563915        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  202202103      ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6568673        ;  Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number  6702024        ;  Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number  J53W69         ;  Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number  J53W09         ;  Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number  J5678H         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J22M91         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J43U77         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J46C04         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J53W73         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J72P53         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J74A28         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8064Y         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8064Z         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8123Z         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8393U         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J43U62         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J37U05         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J4950H         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J46A95         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J4951G         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J53W54         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J53W20         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J5678J         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J74A17         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J5678J         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J74A18         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H50         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J82M03         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H48         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H49         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J79H50         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8670H         ;  Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number  J8393H         ;  Catalog Number PN08CPPCA, UDI/DI 10197106722909 (EA)50197106722907 (CS), Lot Number  7331310        ;  Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number  J46C04         ;  Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number  J4680A         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J30T39         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J53W72         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J4949U         ;  Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number  J53W13         ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  18J2583        ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  J4952C         ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  J4680A         ;  Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number  J4952P         ;  Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number  J6367F         ;  Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number  5138222        ;  Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number  5533338        ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  18B0346        ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J3464G         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  19E1526        ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J53W67         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J37T59         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J30T08         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J6277M         ;  Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number  J5679N         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  19L3475        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J5679H         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  19L3475        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J84K01         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  19L3475        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J84K02         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  5478803        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J82M01         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J7963U         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J82M01         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J7964A         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J8491U         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  J85W30         ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  5324047        ;  Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number  5405629        ;  Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number  5140356        ;  Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number  5138244        ;  Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number  5478803        ;  Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number  5324034        ;  Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number  J6278U         ;  Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number  5324040        ;  Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number  5970334        ;  Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number  6022053        ;  Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number  6025786        ;  Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number  6022060        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6563989        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6563988        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6788561        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928762        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928766        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928764        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7280110        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7287567        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332904        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332909        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6928772        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J8123Z         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J84K02         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J86T83         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5533336        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5618932        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J6278U         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5664100        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5876883        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5888374        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6022130        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6345523        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6264447        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6986974        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7122004        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7260053        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7286184        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7260068        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7280048        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7287483        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7331285        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332804        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  7332837        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J8393A         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J8491U         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J6366D         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5508039        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5530912        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  531025         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  5508041        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  J6277T         ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6485589        ;  Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number  6687082        ;  Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number  18H2278        ;  Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number  J46C03         ;  Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number  J5678M         ;  Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number  18M3535        ;  Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number  J6050D         ;  Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number  J6365Y         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  18H2205        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J37U06         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  18H2278        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J46A97         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  18H2278        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J22M99         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  19A0124        ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J4952M         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J3986K         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J4679C         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J4950G         ;  Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number  J53W13         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J30T25         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J3987C         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J4678K         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J4219Z         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J46A89         ;  Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number  J37U13         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J4219N         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J43U77         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J4679P         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J43U77         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J46A91         ;  Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number  J46C06         ;  Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number  J46A88         ;  Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number  J46A98         ;  Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number  J4680D         ;  Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number  J4951X         ;  Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number  J4952R         ;  Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number  J6366K         ;  Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number  N/A            ;  Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number  J72P53         ;  Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number  J72P50         ;  Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number  J7498U         ;  Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number  J5679T         ;  Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number  N/A            ;  Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number  J7498G         ;  Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number  J74A30         ;  Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number  J7609N         ;  Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number  J6366T         ;  Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number  N/A            ;  Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number  J74A38         ;  Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number  J7498J         ;  Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number  J7704F         ;  Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number  J5678R         ;  Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number  J7704C         ;  Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number  J74A38         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J4951H         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  N/A            ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J53W68         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J53W37         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J5679D         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J7904W         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J7963H         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J8064Z         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J84J95         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J7963D         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J85W16         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J8123Z         ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  N/A            ;  Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number  J8670X         ;  Catalog Number PN23CFAHA, UD",
            "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"
          }
        }
      ]
    }
  ]
}