{
  "@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",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2627-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;  2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;  3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI;  4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;  5) CATH LAB PACK , Pack Number 00-398725AM;  6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ;  7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ;  8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ;  9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ;  10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ;  11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ;  12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC;  13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD;  14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ;  15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ;  16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ;  17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ;  18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ;  19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ;  20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ;  21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ;  22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ;  23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ;  24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ;  25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ;  26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ;  27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ;  28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA;  29) CATH LAB PACK-LF, Pack Number 00-HCT055P ;  30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G;  31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I;  32) ANGIO PACK, Pack Number 0M-CP31933C;  33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I;  34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J;  35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ;  36) CABG 1, Pack Number CDS983663J ;  37) CATH CDS, Pack Number CDS984141I ;  38) ENDO AAA, Pack Number CDS984264I ;  39) ANGIOGRAPHY OR, Pack Number CDS984944C ;  40) ACCESS CATHETER , Pack Number CDS985507F ;  41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ;  42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ;  43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ;  44) NEURO ANGIO PACK, Pack Number DYNDA1431A;  45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ;  46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ;  47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ;  48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ;  49) ANGIOGRAM , Pack Number DYNJ0149444J ;  50) ANGIOGRAM , Pack Number DYNJ0149444K ;  51) ANGIOGRAM , Pack Number DYNJ0149444M ;  52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ;  53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ;  54) no name , Pack Number DYNJ0161241F ;  55) ANGIO PACK-LF , Pack Number DYNJ0165039M ;  56) ANGIO PACK-LF , Pack Number DYNJ0165039N ;  57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;  58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;  59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;  60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;  61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;  62) ANGIO PACK-LF , Pack Number DYNJ0281048I ;  63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;  64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;  65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;  66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;  67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;  68) CATH PACK-LF, Pack Number DYNJ0367643Q ;  69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;  70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;  71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;  72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;  73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;  74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;  75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ",
  "description": "FDA recall Z-2627-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;  2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;  3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI;  4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;  5) CATH LAB PACK , Pack Number 00-398725AM;  6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ;  7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ;  8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ;  9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ;  10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ;  11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ;  12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC;  13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD;  14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ;  15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ;  16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ;  17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ;  18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ;  19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ;  20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ;  21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ;  22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ;  23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ;  24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ;  25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ;  26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ;  27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ;  28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA;  29) CATH LAB PACK-LF, Pack Number 00-HCT055P ;  30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G;  31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I;  32) ANGIO PACK, Pack Number 0M-CP31933C;  33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I;  34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J;  35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ;  36) CABG 1, Pack Number CDS983663J ;  37) CATH CDS, Pack Number CDS984141I ;  38) ENDO AAA, Pack Number CDS984264I ;  39) ANGIOGRAPHY OR, Pack Number CDS984944C ;  40) ACCESS CATHETER , Pack Number CDS985507F ;  41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ;  42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ;  43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ;  44) NEURO ANGIO PACK, Pack Number DYNDA1431A;  45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ;  46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ;  47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ;  48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ;  49) ANGIOGRAM , Pack Number DYNJ0149444J ;  50) ANGIOGRAM , Pack Number DYNJ0149444K ;  51) ANGIOGRAM , Pack Number DYNJ0149444M ;  52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ;  53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ;  54) no name , Pack Number DYNJ0161241F ;  55) ANGIO PACK-LF , Pack Number DYNJ0165039M ;  56) ANGIO PACK-LF , Pack Number DYNJ0165039N ;  57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;  58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;  59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;  60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;  61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;  62) ANGIO PACK-LF , Pack Number DYNJ0281048I ;  63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;  64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;  65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;  66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;  67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;  68) CATH PACK-LF, Pack Number DYNJ0367643Q ;  69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;  70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;  71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;  72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;  73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;  74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;  75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ (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-2627-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;  2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;  3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI;  4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;  5) CATH LAB PACK , Pack Number 00-398725AM;  6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ;  7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ;  8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ;  9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ;  10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ;  11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ;  12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC;  13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD;  14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ;  15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ;  16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ;  17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ;  18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ;  19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ;  20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ;  21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ;  22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ;  23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ;  24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ;  25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ;  26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ;  27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ;  28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA;  29) CATH LAB PACK-LF, Pack Number 00-HCT055P ;  30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G;  31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I;  32) ANGIO PACK, Pack Number 0M-CP31933C;  33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I;  34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J;  35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ;  36) CABG 1, Pack Number CDS983663J ;  37) CATH CDS, Pack Number CDS984141I ;  38) ENDO AAA, Pack Number CDS984264I ;  39) ANGIOGRAPHY OR, Pack Number CDS984944C ;  40) ACCESS CATHETER , Pack Number CDS985507F ;  41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ;  42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ;  43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ;  44) NEURO ANGIO PACK, Pack Number DYNDA1431A;  45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ;  46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ;  47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ;  48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ;  49) ANGIOGRAM , Pack Number DYNJ0149444J ;  50) ANGIOGRAM , Pack Number DYNJ0149444K ;  51) ANGIOGRAM , Pack Number DYNJ0149444M ;  52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ;  53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ;  54) no name , Pack Number DYNJ0161241F ;  55) ANGIO PACK-LF , Pack Number DYNJ0165039M ;  56) ANGIO PACK-LF , Pack Number DYNJ0165039N ;  57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;  58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;  59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;  60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;  61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;  62) ANGIO PACK-LF , Pack Number DYNJ0281048I ;  63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;  64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;  65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;  66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;  67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;  68) CATH PACK-LF, Pack Number DYNJ0367643Q ;  69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;  70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;  71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;  72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;  73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;  74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;  75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2627-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2627-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;  2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;  3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI;  4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;  5) CATH LAB PACK , Pack Number 00-398725AM;  6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ;  7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ;  8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ;  9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ;  10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ;  11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ;  12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC;  13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD;  14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ;  15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ;  16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ;  17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ;  18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ;  19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ;  20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ;  21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ;  22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ;  23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ;  24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ;  25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ;  26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ;  27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ;  28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA;  29) CATH LAB PACK-LF, Pack Number 00-HCT055P ;  30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G;  31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I;  32) ANGIO PACK, Pack Number 0M-CP31933C;  33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I;  34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J;  35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ;  36) CABG 1, Pack Number CDS983663J ;  37) CATH CDS, Pack Number CDS984141I ;  38) ENDO AAA, Pack Number CDS984264I ;  39) ANGIOGRAPHY OR, Pack Number CDS984944C ;  40) ACCESS CATHETER , Pack Number CDS985507F ;  41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ;  42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ;  43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ;  44) NEURO ANGIO PACK, Pack Number DYNDA1431A;  45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ;  46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ;  47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ;  48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ;  49) ANGIOGRAM , Pack Number DYNJ0149444J ;  50) ANGIOGRAM , Pack Number DYNJ0149444K ;  51) ANGIOGRAM , Pack Number DYNJ0149444M ;  52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ;  53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ;  54) no name , Pack Number DYNJ0161241F ;  55) ANGIO PACK-LF , Pack Number DYNJ0165039M ;  56) ANGIO PACK-LF , Pack Number DYNJ0165039N ;  57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;  58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;  59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;  60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;  61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;  62) ANGIO PACK-LF , Pack Number DYNJ0281048I ;  63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;  64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;  65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;  66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;  67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;  68) CATH PACK-LF, Pack Number DYNJ0367643Q ;  69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;  70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;  71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;  72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;  73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;  74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;  75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ",
      "text": "The FDA logged enforcement record Z-2627-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;  2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;  3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI;  4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;  5) CATH LAB PACK , Pack Number 00-398725AM;  6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ;  7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ;  8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ;  9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ;  10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ;  11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ;  12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC;  13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD;  14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ;  15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ;  16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ;  17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ;  18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ;  19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ;  20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ;  21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ;  22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ;  23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ;  24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ;  25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ;  26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ;  27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ;  28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA;  29) CATH LAB PACK-LF, Pack Number 00-HCT055P ;  30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G;  31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I;  32) ANGIO PACK, Pack Number 0M-CP31933C;  33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I;  34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J;  35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ;  36) CABG 1, Pack Number CDS983663J ;  37) CATH CDS, Pack Number CDS984141I ;  38) ENDO AAA, Pack Number CDS984264I ;  39) ANGIOGRAPHY OR, Pack Number CDS984944C ;  40) ACCESS CATHETER , Pack Number CDS985507F ;  41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ;  42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ;  43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ;  44) NEURO ANGIO PACK, Pack Number DYNDA1431A;  45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ;  46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ;  47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ;  48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ;  49) ANGIOGRAM , Pack Number DYNJ0149444J ;  50) ANGIOGRAM , Pack Number DYNJ0149444K ;  51) ANGIOGRAM , Pack Number DYNJ0149444M ;  52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ;  53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ;  54) no name , Pack Number DYNJ0161241F ;  55) ANGIO PACK-LF , Pack Number DYNJ0165039M ;  56) ANGIO PACK-LF , Pack Number DYNJ0165039N ;  57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;  58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;  59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;  60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;  61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;  62) ANGIO PACK-LF , Pack Number DYNJ0281048I ;  63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;  64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;  65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;  66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;  67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;  68) CATH PACK-LF, Pack Number DYNJ0367643Q ;  69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;  70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;  71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;  72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;  73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;  74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;  75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: 00-398281J , Lot Number 19FBL693 ;  00-398281J , Lot Number 19HBQ768 ;  00-398281J , Lot Number 19IBJ984 ;  00-398281J , Lot Number 19JBM853 ;  00-398650AG, Lot Number 19ABM946 ;  00-398650AG, Lot Number 19BBS748 ;  00-398650AG, Lot Number 19CBJ825 ;  00-398650AG, Lot Number 19DBR708 ;  00-398650AG, Lot Number 19FBR243 ;  00-398650AG, Lot Number 19IBV635 ;  00-398650AG, Lot Number 19KBL462 ;  00-398650AG, Lot Number 20MBA140 ;  00-398650AG, Lot Number 20EBE408 ;  00-398650AG, Lot Number 20FBJ771 ;  00-398650AG, Lot Number 20HBI575 ;  00-398650AG, Lot Number 20JBJ100 ;  00-398650AG, Lot Number 21ABP363 ;  00-398650AG, Lot Number 21ABQ027 ;  00-398650AI, Lot Number 21FBT441 ;  00-398650AI, Lot Number 21IBH355 ;  00-398650AI, Lot Number 21KBM869 ;  00-398650AI, Lot Number 21LBH937 ;  00-398650AI, Lot Number 22BBA596 ;  00-398650AI, Lot Number 22CBY494 ;  00-398650AI, Lot Number 22DBQ496 ;  00-398650AI, Lot Number 22FBL546 ;  00-398650AI, Lot Number 22GBJ321 ;  00-398650AI, Lot Number 22JBE607 ;  00-398650AI, Lot Number 22JBE609 ;  00-398650AI, Lot Number 21EBB527 ;  00-398712S , Lot Number 19KMA101 ;  00-398712S , Lot Number 19LMB722 ;  00-398712S , Lot Number 20CMA260 ;  00-398712S , Lot Number 20CMC911 ;  00-398712S , Lot Number 20FMA921 ;  00-398712S , Lot Number 20GMB435 ;  00-398712S , Lot Number 20IMA653 ;  00-398712S , Lot Number 20KMA809 ;  00-398712S , Lot Number 20LMD895 ;  00-398712S , Lot Number 21CMD722 ;  00-398712S , Lot Number 21EMF323 ;  00-398712S , Lot Number 21HMB142 ;  00-398712S , Lot Number 21IMB825 ;  00-398712S , Lot Number 21JMH910 ;  00-398712S , Lot Number 21LMG148 ;  00-398712S , Lot Number 22BMH320 ;  00-398712S , Lot Number 22DME594 ;  00-398712S , Lot Number 22HMI166 ;  00-398712S , Lot Number 22JME059 ;  00-398712S , Lot Number 23AME236 ;  00-398712S , Lot Number 23DME416 ;  00-398712S , Lot Number 23FMG905 ;  00-398712S , Lot Number 23IMF984 ;  00-398712S , Lot Number 23KMF990 ;  00-398712S , Lot Number 19BKB212 ;  00-398712S , Lot Number 19CKB198 ;  00-398712S , Lot Number 19EKB257 ;  00-398712S , Lot Number 19GKC485 ;  00-398712S , Lot Number 19IKA568 ;  00-398712S , Lot Number 19IKB991 ;  00-398725AM, Lot Number 21FBJ550 ;  00-398725AM, Lot Number 19IBJ529 ;  00-398725AM, Lot Number 19KBS571 ;  00-398725AM, Lot Number 19KBU397 ;  00-398725AM, Lot Number 20BBE698 ;  00-398725AM, Lot Number 20CBG353 ;  00-398725AM, Lot Number 20DBI198 ;  00-398725AM, Lot Number 20FBB296 ;  00-398725AM, Lot Number 20FBC302 ;  00-398725AM, Lot Number 20GBF723 ;  00-398725AM, Lot Number 20HBM698 ;  00-398725AM, Lot Number 20LBR908 ;  00-398725AM, Lot Number 21BBE202 ;  00-398725AM, Lot Number 21DBD638 ;  00-399360K , Lot Number 21VBC685 ;  00-399360K , Lot Number 23FBU384 ;  00-399360K , Lot Number 23IBA381 ;  00-399360K , Lot Number 23KBE043 ;  00-399360K , Lot Number 23LBR853 ;  00-399734N , Lot Number 23JBU818 ;  00-399734N , Lot Number 23KBI990 ;  00-399734N , Lot Number 23LBV170 ;  00-399734N , Lot Number 19ADB519 ;  00-399734N , Lot Number 19BDB357 ;  00-399734N , Lot Number 19DDA161 ;  00-399734N , Lot Number 19EDA281 ;  00-399734N , Lot Number 19EDC270 ;  00-399734N , Lot Number 19GDA275 ;  00-399734N , Lot Number 19IDA132 ;  00-399734N , Lot Number 19LMA267 ;  00-399734N , Lot Number 20BMA475 ;  00-399734N , Lot Number 20DMA774 ;  00-399734N , Lot Number 20GMB326 ;  00-399734N , Lot Number 20IMD767 ;  00-399734N , Lot Number 20JMC215 ;  00-399734N , Lot Number 21DMA867 ;  00-399734N , Lot Number 21DME739 ;  00-399734N , Lot Number 21FMF556 ;  00-399734N , Lot Number 21IMA047 ;  00-399734N , Lot Number 21JME290 ;  00-399734N , Lot Number 21JMH037 ;  00-399734N , Lot Number 22CMF020 ;  00-399734N , Lot Number 22DMF495 ;  00-399734N , Lot Number 22GMB900 ;  00-399734N , Lot Number 22IMA125 ;  00-399734N , Lot Number 22JME374 ;  00-399734N , Lot Number 22LMB989 ;  00-399734N , Lot Number 23DMA849 ;  00-399734N , Lot Number 23EMC285 ;  00-399734N , Lot Number 23EMJ483 ;  00-399983Q , Lot Number 19BBE921 ;  00-399983Q , Lot Number 19CBY031 ;  00-399983Q , Lot Number 19PBC257 ;  00-399983Q , Lot Number 19FBR534 ;  00-399983Q , Lot Number 19HBF178 ;  00-399983Q , Lot Number 19KBF830 ;  00-399983Q , Lot Number 19LBP680 ;  00-399983Q , Lot Number 20ABX119 ;  00-399983Q , Lot Number 20CBX476 ;  00-399983Q , Lot Number 20EMA308 ;  00-399983Q , Lot Number 20GMA221 ;  00-399983Q , Lot Number 20HMD089 ;  00-399983Q , Lot Number 20JMA848 ;  00-399983Q , Lot Number 20JMC961 ;  00-399983Q , Lot Number 21AMB499 ;  00-399983R , Lot Number 21DMF325 ;  00-399983R , Lot Number 21GMD901 ;  00-399983R , Lot Number 21HMA462 ;  00-399983R , Lot Number 21KMF309 ;  00-399983R , Lot Number 21KMH211 ;  00-399983R , Lot Number 21LMA509 ;  00-399983R , Lot Number 22AME571 ;  00-399983R , Lot Number 22EMC467 ;  00-399983R , Lot Number 22HME724 ;  00-399983R , Lot Number 22KMB997 ;  00-399983R , Lot Number 23AMA130 ;  00-399983R , Lot Number 23CMA230 ;  00-400065K , Lot Number 21FBR263 ;  00-400065K , Lot Number 21HBB836 ;  00-400065K , Lot Number 21JBL879 ;  00-400065K , Lot Number 21KBF878 ;  00-400065K , Lot Number 21LBU544 ;  00-400065K , Lot Number 22BBG118 ;  00-400065K , Lot Number 19ABB720 ;  00-400065K , Lot Number 22CBU488 ;  00-400065K , Lot Number 19BBQ915 ;  00-400065K , Lot Number 19CBM065 ;  00-400065K , Lot Number 22DBP187 ;  00-400065K , Lot Number 19DBM042 ;  00-400065K , Lot Number 22EBP317 ;  00-400065K , Lot Number 19EBX671 ;  00-400065K , Lot Number 22HBF260 ;  00-400065K , Lot Number 19GBN148 ;  00-400065K , Lot Number 22KBG632 ;  00-400065K , Lot Number 19JBB584 ;  00-400065K , Lot Number 19JBI267 ;  00-400065K , Lot Number 22LBO309 ;  00-400065K , Lot Number 23ABG526 ;  00-400065K , Lot Number 23BBQ040 ;  00-400065K , Lot Number 19KBY541 ;  00-400065K , Lot Number 23CBJ011 ;  00-400065K , Lot Number 20MBA423 ;  00-400065K , Lot Number 20CBC516 ;  00-400065K , Lot Number 20DBM271 ;  00-400065K , Lot Number 20FBD765 ;  00-400065K , Lot Number 20GBH479 ;  00-400065K , Lot Number 20HBW054 ;  00-400065K , Lot Number 20JBN060 ;  00-400065K , Lot Number 20KBW249 ;  00-400065K , Lot Number 21BBD722 ;  00-400065K , Lot Number 21CBV490 ;  00-400069F , Lot Number 21GBJ540 ;  00-400069F , Lot Number 21HBN535 ;  00-400069F , Lot Number 21JBV864 ;  00-400069F , Lot Number 19KBY112 ;  00-400069F , Lot Number 19KBZ300 ;  00-400069F , Lot Number 19LBT262 ;  00-400069F , Lot Number 20ABA121 ;  00-400069F , Lot Number 20ABE706 ;  00-400069F , Lot Number 20FBH567 ;  00-400069F , Lot Number 20FBU536 ;  00-400069F , Lot Number 20HBM357 ;  00-400069F , Lot Number 20IBI988 ;  00-400069F , Lot Number 20JBE618 ;  00-400069F , Lot Number 20LBM288 ;  00-400069F , Lot Number 20LBM394 ;  00-400069F , Lot Number 20LBR652 ;  00-400069F , Lot Number 21ABB713 ;  00-400069F , Lot Number 21CBR762 ;  00-400123AC, Lot Number 19ABQ452 ;  00-400123AC, Lot Number 19BBN072 ;  00-400123AC, Lot Number 19BBT797 ;  00-400123AC, Lot Number 19CBR393 ;  00-400123AC, Lot Number 19DBP114 ;  00-400123AC, Lot Number 19EBR874 ;  00-400123AC, Lot Number 19EBZ557 ;  00-400123AC, Lot Number 19GBW344 ;  00-400123AC, Lot Number 19VBA449 ;  00-400123AC, Lot Number 19LBE973 ;  00-400123AC, Lot Number 20BBI940 ;  00-400123AC, Lot Number 20CBU720 ;  00-400123AC, Lot Number 20FBC048 ;  00-400123AD, Lot Number 21GBB662 ;  00-400123AD, Lot Number 21HBE405 ;  00-400123AD, Lot Number 21JBT553 ;  00-400123AD, Lot Number 21JBT555 ;  00-400123AD, Lot Number 21LBM691 ;  00-400123AD, Lot Number 22ABN198 ;  00-400123AD, Lot Number 22EBG139 ;  00-400123AD, Lot Number 22GBB778 ;  00-400123AD, Lot Number 20IBL629 ;  00-400123AD, Lot Number 20JBL358 ;  00-400123AD, Lot Number 21ABG411 ;  00-400123AD, Lot Number 21BBD488 ;  00-400123AD, Lot Number 21CBJ466 ;  00-400290D , Lot Number 21JBL730 ;  00-400290D , Lot Number 21JBL760 ;  00-400290D , Lot Number 22BBL397 ;  00-400290D , Lot Number 22DBD105 ;  00-400290D , Lot Number 22HBX245 ;  00-400290D , Lot Number 22IBJ158 ;  00-400290D , Lot Number 23ABM361 ;  00-400290D , Lot Number 23FBB540 ;  00-400290D , Lot Number 23HBW414 ;  00-400290D , Lot Number 23KBQ874 ;  00-400305Q , Lot Number 21FBH829 ;  00-400305Q , Lot Number 19BBI732 ;  00-400305Q , Lot Number 19CBT638 ;  00-400305Q , Lot Number 19FBK838 ;  00-400305Q , Lot Number 19HBQ608 ;  00-400305Q , Lot Number 19JBF448 ;  00-400305Q , Lot Number 19KBK353 ;  00-400305Q , Lot Number 19LBT845 ;  00-400305Q , Lot Number 20CBX252 ;  00-400305Q , Lot Number 20EBB804 ;  00-400305Q , Lot Number 20EBO003 ;  00-400305Q , Lot Number 20FBD660 ;  00-400305Q , Lot Number 20FBK609 ;  00-400305Q , Lot Number 20GBB363 ;  00-400305Q , Lot Number 20GBT691 ;  00-400305Q , Lot Number 20KBN359 ;  00-400305Q , Lot Number 21ABG937 ;  00-400763F , Lot Number 19ABQ264 ;  00-400763F , Lot Number 19CBJ552 ;  00-400763F , Lot Number 19EBI331 ;  00-400763F , Lot Number 19FBK986 ;  00-400763F , Lot Number 20CBL280 ;  00-400763F , Lot Number 20DBV350 ;  00-400763F , Lot Number 20FBI815 ;  00-400763F , Lot Number 20HBD412 ;  00-400763F , Lot Number 20XBG604 ;  00-400763F , Lot Number 21ABL875 ;  00-400763F , Lot Number 21BBC738 ;  00-400863J , Lot Number 22HBU529 ;  00-400863J , Lot Number 23ABJ577 ;  00-400932O , Lot Number 19BBU120 ;  00-400932O , Lot Number 19CBR446 ;  00-400932O , Lot Number 19EBA051 ;  00-400932O , Lot Number 19FBB043 ;  00-401030S , Lot Number 19ABV014 ;  00-401030S , Lot Number 19CBE728 ;  00-401030S , Lot Number 19DBG910 ;  00-401030S , Lot Number 19QBC207 ;  00-401030S , Lot Number 19FBK697 ;  00-401030S , Lot Number 19JBH635 ;  00-401030S , Lot Number 19KBH432 ;  00-401030S , Lot Number 20BBS390 ;  00-401030S , Lot Number 23HBC817 ;  00-401030S , Lot Number 23IBG655 ;  00-401030S , Lot Number 23JBU657 ;  00-401030S , Lot Number 23LBA284 ;  00-401030S , Lot Number 23LBK479 ;  00-401030S , Lot Number 20FMB629 ;  00-401030S , Lot Number 20HMA737 ;  00-401030S , Lot Number 20IMB800 ;  00-401030S , Lot Number 20JMD194 ;  00-401030S , Lot Number 20LMC207 ;  00-401030S , Lot Number 20LME822 ;  00-401030S , Lot Number 21GMC427 ;  00-401030S , Lot Number 21IMA147 ;  00-401030S , Lot Number 21IME724 ;  00-401030S , Lot Number 22AMB985 ;  00-401030S , Lot Number 22AMG093 ;  00-401030S , Lot Number 22BMF120 ;  00-401030S , Lot Number 22EMC963 ;  00-401030S , Lot Number 22FMF626 ;  00-401030S , Lot Number 22IMB853 ;  00-401030S , Lot Number 22JME308 ;  00-401030S , Lot Number 22KMG715 ;  00-401030S , Lot Number 23BMA914 ;  00-401030S , Lot Number 23BME201 ;  00-401030S , Lot Number 23DMB789 ;  00-401030S , Lot Number 23EMC356 ;  00-401030S , Lot Number 23FMB166 ;  00-401178D , Lot Number 21GBC991 ;  00-401178D , Lot Number 21KBI883 ;  00-401178D , Lot Number 21LBM169 ;  00-401178D , Lot Number 22ABX434 ;  00-401178D , Lot Number 19ABG094 ;  00-401178D , Lot Number 22BBW843 ;  00-401178D , Lot Number 19DBE720 ;  00-401178D , Lot Number 22EBH149 ;  00-401178D , Lot Number 22EBM830 ;  00-401178D , Lot Number 22FBC591 ;  00-401178D , Lot Number 19QBB031 ;  00-401178D , Lot Number 19FBO535 ;  00-401178D , Lot Number 19HBD335 ;  00-401178D , Lot Number 19HBL210 ; 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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-2627-2024&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-2627-2024&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-2627-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2627-2024 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",
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      "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-2627-2024&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-2627-2024&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-2627-2024/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",
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      "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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          "item": {
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          "item": {
            "Field": "Reason",
            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
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            "Field": "Initiated",
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 00-400065K , Lot Number 20KBW249 ;  00-400065K , Lot Number 21BBD722 ;  00-400065K , Lot Number 21CBV490 ;  00-400069F , Lot Number 21GBJ540 ;  00-400069F , Lot Number 21HBN535 ;  00-400069F , Lot Number 21JBV864 ;  00-400069F , Lot Number 19KBY112 ;  00-400069F , Lot Number 19KBZ300 ;  00-400069F , Lot Number 19LBT262 ;  00-400069F , Lot Number 20ABA121 ;  00-400069F , Lot Number 20ABE706 ;  00-400069F , Lot Number 20FBH567 ;  00-400069F , Lot Number 20FBU536 ;  00-400069F , Lot Number 20HBM357 ;  00-400069F , Lot Number 20IBI988 ;  00-400069F , Lot Number 20JBE618 ;  00-400069F , Lot Number 20LBM288 ;  00-400069F , Lot Number 20LBM394 ;  00-400069F , Lot Number 20LBR652 ;  00-400069F , Lot Number 21ABB713 ;  00-400069F , Lot Number 21CBR762 ;  00-400123AC, Lot Number 19ABQ452 ;  00-400123AC, Lot Number 19BBN072 ;  00-400123AC, Lot Number 19BBT797 ;  00-400123AC, Lot Number 19CBR393 ;  00-400123AC, Lot Number 19DBP114 ;  00-400123AC, Lot Number 19EBR874 ;  00-400123AC, Lot Number 19EBZ557 ; 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 CDS984264I , Lot Number 20LBD863 ;  CDS984264I , Lot Number 21CBU211 ;  CDS984944C , Lot Number 21GBH369 ;  CDS984944C , Lot Number 21JBH079 ;  CDS984944C , Lot Number 21JBH447 ;  CDS984944C , Lot Number 22ABO062 ;  CDS984944C , Lot Number 19BBK863 ;  CDS984944C , Lot Number 22CBS264 ;  CDS984944C , Lot Number 19DBF305 ;  CDS984944C , Lot Number 22DBR207 ;  CDS984944C , Lot Number 19FBH023 ;  CDS984944C , Lot Number 22GBN686 ;  CDS984944C , Lot Number 22HBP396 ;  CDS984944C , Lot Number 19TBC645 ;  CDS984944C , Lot Number 19JBL301 ;  CDS984944C , Lot Number 23ABE699 ;  CDS984944C , Lot Number 23BBB682 ;  CDS984944C , Lot Number 19KBH812 ;  CDS984944C , Lot Number 23BBT174 ;  CDS984944C , Lot Number 23CBP534 ;  CDS984944C , Lot Number 23DBH568 ;  CDS984944C , Lot Number 20ABU824 ;  CDS984944C , Lot Number 20BBW831 ;  CDS984944C , Lot Number 20DBU240 ;  CDS984944C , Lot Number 20EBD325 ;  CDS984944C , Lot Number 20HBP059 ;  CDS984944C , Lot Number 20HBQ698 ;  CDS984944C , Lot Number 20IBI239 ; 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 DYNJ0048560A , Lot Number 23ABT155 ;  DYNJ0048560A , Lot Number 23CBH483 ;  DYNJ0048560A , Lot Number 20ABR325 ;  DYNJ0048560A , Lot Number 20DBH858 ;  DYNJ0048560A , Lot Number 20GBC399 ;  DYNJ0048560A , Lot Number 20HBE262 ;  DYNJ0048560A , Lot Number 20JBG698 ;  DYNJ0048560A , Lot Number 20KBC215 ;  DYNJ0048560A , Lot Number 21ABV135 ;  DYNJ0048560A , Lot Number 21CBC529 ;  DYNJ0048560A , Lot Number 21DBR467 ;  DYNJ0101429L , Lot Number 19HDA131 ;  DYNJ0101429N , Lot Number 21HME827 ;  DYNJ0101429N , Lot Number 21IMH933 ;  DYNJ0101429N , Lot Number 21KMH061 ;  DYNJ0101429N , Lot Number 21LMC138 ;  DYNJ0101429N , Lot Number 22BMD129 ;  DYNJ0101429N , Lot Number 22CME375 ;  DYNJ0101429N , Lot Number 22DMI802 ;  DYNJ0131200P , Lot Number 21AMC025 ;  DYNJ0131200P , Lot Number 19BKB309 ;  DYNJ0131200P , Lot Number 19DKA637 ;  DYNJ0131200P , Lot Number 19FKA261 ;  DYNJ0131200P , Lot Number 19GKC167 ;  DYNJ0131200P , Lot Number 19IKA087 ;  DYNJ0131200P , Lot Number 19KKA248 ;  DYNJ0131200P , Lot Number 20GKA203 ;  DYNJ0149444J , Lot Number 19BKC754 ;  DYNJ0149444J , Lot Number 19CKD084 ;  DYNJ0149444J , Lot Number 19EKB920 ;  DYNJ0149444K , Lot Number 19IKA479 ;  DYNJ0149444M , Lot Number 21EMA476 ;  DYNJ0149444M , Lot Number 21IMB706 ;  DYNJ0149444M , Lot Number 20KKA911 ;  DYNJ0149444M , Lot Number 20LKA376 ;  DYNJ0149444M , Lot Number 21CKA033 ;  DYNJ0160556D , Lot Number 19KDA450 ;  DYNJ0160556D , Lot Number 20ADC138 ;  DYNJ0160556D , Lot Number 20CDB331 ;  DYNJ0160556D , Lot Number 20EDB622 ;  DYNJ0160556D , Lot Number 20HDB293 ;  DYNJ0160556D , Lot Number 20JDC793 ;  DYNJ0160556D , Lot Number 20KDA939 ;  DYNJ0160556D , Lot Number 20LDA690 ;  DYNJ0160556D , Lot Number 21EDA857 ;  DYNJ0160556D , Lot Number 21GDC359 ;  DYNJ0160556D , Lot Number 21IDA620 ;  DYNJ0160556D , Lot Number 22ADA878 ;  DYNJ0160556D , Lot Number 22BDA152 ;  DYNJ0160556D , Lot Number 22DDA765 ;  DYNJ0160556D , Lot Number 22GDB640 ;  DYNJ0160556D , Lot Number 22GDB975 ;  DYNJ0160556D , Lot Number 22JDA514 ;  DYNJ0160556D , Lot Number 23BDA568 ;  DYNJ0161241F , Lot Number 20BDA735 ;  DYNJ0161241F , Lot Number 20CDB736 ;  DYNJ0161241F , Lot Number 20GDB449 ;  DYNJ0161241F , Lot Number 20IDA082 ;  DYNJ0161241F , Lot Number 20KDA354 ;  DYNJ0161241F , Lot Number 20LDB702 ;  DYNJ0161241F , Lot Number 21FDA333 ;  DYNJ0161241F , Lot Number 21FDC117 ;  DYNJ0161241F , Lot Number 21GDD174 ;  DYNJ0161241F , Lot Number 21IDB617 ;  DYNJ0161241F , Lot Number 21KDC480 ;  DYNJ0161241F , Lot Number 22CDA923 ;  DYNJ0161241F , Lot Number 22FDB089 ;  DYNJ0161241F , Lot Number 22GDB301 ;  DYNJ0161241F , Lot Number 22HDA066 ;  DYNJ0161241F , Lot Number 22IDA273 ;  DYNJ0161241F , Lot Number 22KDB022 ;  DYNJ0161241F , Lot Number 23ADB121 ;  DYNJ0161241F , Lot Number 23ADB642 ;  DYNJ0161241F , Lot Number 23CDC525 ;  DYNJ0161241F , Lot Number 23FDB083 ;  DYNJ0161241F , Lot Number 23HDB338 ;  DYNJ0161241F , Lot Number 23IDC123 ;  DYNJ0161241F , Lot Number 23JDB460 ;  DYNJ0161241F , Lot Number 23LDC122 ;  DYNJ0161241F , Lot Number 24CDA742 ;  DYNJ0165039M , Lot Number 20LMC012 ;  DYNJ0165039M , Lot Number 21BMB999 ;  DYNJ0165039M , Lot Number 21CMA971 ;  DYNJ0165039M , Lot Number 19AKA997 ;  DYNJ0165039M , Lot Number 19AKD298 ;  DYNJ0165039M , Lot Number 19CKA034 ;  DYNJ0165039M , Lot Number 19DKD120 ;  DYNJ0165039M , Lot Number 19FKC588 ;  DYNJ0165039M , Lot Number 19HKB202 ;  DYNJ0165039M , Lot Number 19IKB966 ;  DYNJ0165039M , Lot Number 19KKB215 ;  DYNJ0165039M , Lot Number 20AKC217 ;  DYNJ0165039M , Lot Number 20DKA921 ;  DYNJ0165039M , Lot Number 20GKA483 ;  DYNJ0165039N , Lot Number 21GMA437 ;  DYNJ0165039N , Lot Number 21IMB664 ;  DYNJ0165039N , Lot Number 21JME773 ;  DYNJ0165039N , Lot Number 21KMC056 ;  DYNJ0165039N , Lot Number 22AMB945 ;  DYNJ0165039N , Lot Number 22DMD177 ;  DYNJ0165039N , Lot Number 22EMA803 ;  DYNJ0165039N , Lot Number 22GMG452 ;  DYNJ0165039N , Lot Number 22IMF336 ;  DYNJ0165039N , Lot Number 22IMG205 ;  DYNJ0165039N , Lot Number 22KMC942 ;  DYNJ0165039N , Lot Number 23AMA481 ;  DYNJ0165039N , Lot Number 23BMB999 ;  DYNJ0165039N , Lot Number 23CMA964 ;  DYNJ0165039N , Lot Number 23CME707 ;  DYNJ0165039N , Lot Number 23DME460 ;  DYNJ0165039N , Lot Number 23EMH215 ;  DYNJ0194989AF, Lot Number 19BKC239 ;  DYNJ0194989AF, Lot Number 19CKD939 ;  DYNJ0194989AF, Lot Number 19EKC339 ;  DYNJ0194989AG, Lot Number 21HMF548 ;  DYNJ0194989AG, Lot Number 21IMF017 ;  DYNJ0194989AG, Lot Number 21KMF814 ;  DYNJ0194989AG, Lot Number 22AMF939 ;  DYNJ0194989AG, Lot Number 22CMB010 ;  DYNJ0201109AG, Lot Number 21GBH202 ;  DYNJ0201109AG, Lot Number 21HBC779 ;  DYNJ0201109AG, Lot Number 21IBR980 ;  DYNJ0201109AG, Lot Number 21JBY989 ;  DYNJ0201109AG, Lot Number 21VBC419 ;  DYNJ0201109AG, Lot Number 22ABR950 ;  DYNJ0201109AG, Lot Number 22BBQ567 ;  DYNJ0201109AG, Lot Number 21CBO991 ;  DYNJ0201109AG, Lot Number 21DBA870 ;  DYNJ0201109AG, Lot Number 21DBS763 ;  DYNJ0201109AG, Lot Number 21EBS525 ;  DYNJ0220880V , Lot Number 21FLA083 ;  DYNJ0220880V , Lot Number 21ILA147 ;  DYNJ0220880V , Lot Number 21KLA059 ;  DYNJ0220880V , Lot Number 22ALA070 ;  DYNJ0220880V , Lot Number 22ALA656 ;  DYNJ0220880V , Lot Number 22ALA849 ;  DYNJ0220880V , Lot Number 22DLA707 ;  DYNJ0220880V , Lot Number 22FLA700 ;  DYNJ0220880V , Lot Number 22HLA272 ;  DYNJ0220880V , Lot Number 22ILA188 ;  DYNJ0220880V , Lot Number 22ILA237 ;  DYNJ0220880V , Lot Number 22ILA641 ;  DYNJ0220880V , Lot Number 22JLA662 ;  DYNJ0220880V , Lot Number 22KLA379 ;  DYNJ0220880V , Lot Number 22KLA836 ;  DYNJ0220880V , Lot Number 22KLA939 ;  DYNJ0220880V , Lot Number 22LLA399 ;  DYNJ0220880V , Lot Number 23HLA505 ;  DYNJ0220880V , Lot Number 23HLB257 ;  DYNJ0220880V , Lot Number 23ILB004 ;  DYNJ0220880V , Lot Number 23JLA021 ;  DYNJ0220880V , Lot Number 23JLA059 ;  DYNJ0220880V , Lot Number 23KLA121 ;  DYNJ0220880V , Lot Number 23KLA231 ;  DYNJ0220880V , Lot Number 23KLA582 ;  DYNJ0220880V , Lot Number 23LLA817 ;  DYNJ0241256L , Lot Number 19CKA699 ;  DYNJ0241256L , Lot Number 19GKC060 ;  DYNJ0241256L , Lot Number 19HKC738 ;  DYNJ0241256L , Lot Number 19IKB047 ;  DYNJ0241256L , Lot Number 19KKA067 ;  DYNJ0281048I , Lot Number 19EBN094 ;  DYNJ0281048I , Lot Number 19FBA415 ;  DYNJ0281048I , Lot Number 19HBB404 ;  DYNJ0281048I , Lot Number 19TBA959 ;  DYNJ0281048I , Lot Number 19KBB264 ;  DYNJ0281048I , Lot Number 19KBM898 ;  DYNJ0281048I , Lot Number 19LBX426 ;  DYNJ0281048I , Lot Number 20BBL584 ;  DYNJ0281048I , Lot Number 20BBY732 ;  DYNJ0281048I , Lot Number 20DBA803 ;  DYNJ0281048I , Lot Number 20EMB802 ;  DYNJ0281048I , Lot Number 20GMA065 ;  DYNJ0281048I , Lot Number 20GMD073 ;  DYNJ0281048I , Lot Number 20IMA406 ;  DYNJ0281048I , Lot Number 20KMB107 ;  DYNJ0281048I , Lot Number 20LMB915 ;  DYNJ0281048I , Lot Number 20LMF792 ;  DYNJ0281048I , Lot Number 21DMB584 ;  DYNJ0281048I , Lot Number 21DMF017 ;  DYNJ0281048I , Lot Number 21FMD971 ;  DYNJ0281048I , Lot Number 21HMA956 ;  DYNJ0281048I , Lot Number 21JME699 ;  DYNJ0281048I , Lot Number 21LMA239 ;  DYNJ0281048I , Lot Number 18LKD415 ;  DYNJ0281048I , Lot Number 19BKB712 ;  DYNJ0281048I , Lot Number 19CKB580 ;  DYNJ0281048I , Lot Number 19EKB261 ;  DYNJ0290716L , Lot Number 21FBQ865 ;  DYNJ0290716L , Lot Number 21HBK454 ;  DYNJ0290716L , Lot Number 21IBL466 ;  DYNJ0290716L , Lot Number 21LBL165 ;  DYNJ0290716L , Lot Number 21EBL353 ;  DYNJ0298504AG, Lot Number 19AKC049 ;  DYNJ0298504AG, Lot Num",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}