{
  "@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-2997-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) PUNCTURE TRAY , Pack Number 00-401649G ;  2) PICC LINE TRAY, Pack Number 00-401993O ;  3) ARTERIOGRAM TRAY, Pack Number 00-402001T ;  4) ARTERIOGRAM TRAY, Pack Number 00-402001U ;  5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;  6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ;  7) AV FISTULA PACK , Pack Number CDS840188M ;  8) VP SHUNT, Pack Number CDS840193V ;  9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ;  10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ;  11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH;  12) CENTRAL LINE CDS, Pack Number CDS930092V ;  13) CENTRAL LINE CDS, Pack Number CDS930092W ;  14) CENTRAL LINE CDS, Pack Number CDS930092X ;  15) C LINE INSERTION CDS, Pack Number CDS980379I ;  16) C LINE INSERTION CDS, Pack Number CDS980379J ;  17) AV FISTULA - SMH, Pack Number CDS980916L ;  18) AV FISTULA CDS, Pack Number CDS981513G ;  19) VASCULAR ACCESS CDS , Pack Number CDS981552F ;  20) VP SHUNT CDS, Pack Number CDS981740G ;  21) VP SHUNT CDS, Pack Number CDS981740I ;  22) PORT A CATH , Pack Number CDS982047Q ;  23) SHY VP SHUNT CDS, Pack Number CDS982389J;  24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ;  25) A-V FISTULA , Pack Number CDS982637K ;  26) A-V FISTULA , Pack Number CDS982637L ;  27) VASCULAR TRAUMA , Pack Number CDS982641K ;  28) AV FISTULA CDS, Pack Number CDS982660G ;  29) AV FISTULA CDS, Pack Number CDS982660I ;  30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ;  31) AV FISTULA/ACCESS , Pack Number CDS983060I ;  32) AV FISTULA/ACCESS , Pack Number CDS983060J ;  33) AV SHUNT CDS, Pack Number CDS983098B ;  34) AV SHUNT CDS, Pack Number CDS983098C ;  35) VASCULAR ACCESS CDS , Pack Number CDS983105C ;  36) VP SHUNT, Pack Number CDS983366K ;  37) VP SHUNT, Pack Number CDS983366L ;  38) AV FISTULA, Pack Number CDS983638G ;  39) AV FISTULA, Pack Number CDS983638I ;  40) AV FISTULA, Pack Number CDS983638J ;  41) BARIATRIC CDS , Pack Number CDS983657J ;  42) BARIATRIC CDS , Pack Number CDS983657K ;  43) BARIATRIC CDS , Pack Number CDS983883C ;  44) GROTH AV FISTULA CDS, Pack Number CDS984191P ;  45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ;  46) GROTH AV FISTULA CDS, Pack Number CDS984191S ;  47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ;  48) GROTH LASER VEIN, Pack Number CDS984193R;  49) SHY AV FISTULA CDS, Pack Number CDS984512G ;  50) AV FISTULA, Pack Number CDS985510G ;  51) THORACOSTOMY TRAY , Pack Number CHT2010;  52) TRAUMA CHEST TUBE SET , Pack Number CHT2015;  53) BARD MYPICC$ KIT, Pack Number CK000234A;  54) BARD MYPICC$ KIT, Pack Number CK000236A;  55) BARD MYPICC$ KIT, Pack Number CK000324 ;  56) BARD MYPICC$ KIT, Pack Number CK000325 ;  57) BARD MYPICC$ KIT, Pack Number CK000645A;  58) BARD MYPICC$ KIT, Pack Number CK000646A;  59) BARD MYPICC$ KIT, Pack Number CK000647A;  60) BARD MYPICC$ KIT, Pack Number CK000713 ;  61) BARD MYPICC$ KIT, Pack Number CK000714 ;  62) CENTRAL LINE TRAY , Pack Number CVI4705;  63) CVC INSERTION PACK, Pack Number CVI4720;  64) ****, Pack Number CVI4720B ;  65) KIT LINE INSERTION, Pack Number CVI4730;  66) KIT LINE INSERTION, Pack Number CVI4730A ;  67) VENOUS ACCESS TRAY, Pack Number CVI4830B ;  68) PORT INSERTION PACK , Pack Number CVI4870;  69) MVHS CVC LUMEN TRAY , Pack Number CVI4920;  70) NO CATHETER BUNDLE, Pack Number CVI4925A ;  71) UAMS PORT INSERTION KIT , Pack Number CVI5040;  72) CVL INSERTION PACK, Pack Number CVI5065;  73) CVL INSERTION PACK, Pack Number CVI5065H ;  74) HEMODIALYSIS TRAY , Pack Number DT8800 ;  75) ERCP KIT, Pack Number DYKE1006A;  76) PULMONARY KIT , Pack Number DYKE1870 ;  77) PULMONARY KIT, Pack Number DYKE1870H;  78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A;  79) ULTRASOUND PACK , Pack Number DYNDA1249A ;  80) CT SCAN-TC, Pack Number DYNDA1380A ;  81) CT SCAN-TC, Pack Number DYNDA1380AH;  82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077;  83) BAL KIT , Pack Number DYNDA2137B ;  84) STERILE PRE OP PACK , Pack Number",
  "description": "FDA recall Z-2997-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) PUNCTURE TRAY , Pack Number 00-401649G ;  2) PICC LINE TRAY, Pack Number 00-401993O ;  3) ARTERIOGRAM TRAY, Pack Number 00-402001T ;  4) ARTERIOGRAM TRAY, Pack Number 00-402001U ;  5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;  6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ;  7) AV FISTULA PACK , Pack Number CDS840188M ;  8) VP SHUNT, Pack Number CDS840193V ;  9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ;  10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ;  11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH;  12) CENTRAL LINE CDS, Pack Number CDS930092V ;  13) CENTRAL LINE CDS, Pack Number CDS930092W ;  14) CENTRAL LINE CDS, Pack Number CDS930092X ;  15) C LINE INSERTION CDS, Pack Number CDS980379I ;  16) C LINE INSERTION CDS, Pack Number CDS980379J ;  17) AV FISTULA - SMH, Pack Number CDS980916L ;  18) AV FISTULA CDS, Pack Number CDS981513G ;  19) VASCULAR ACCESS CDS , Pack Number CDS981552F ;  20) VP SHUNT CDS, Pack Number CDS981740G ;  21) VP SHUNT CDS, Pack Number CDS981740I ;  22) PORT A CATH , Pack Number CDS982047Q ;  23) SHY VP SHUNT CDS, Pack Number CDS982389J;  24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ;  25) A-V FISTULA , Pack Number CDS982637K ;  26) A-V FISTULA , Pack Number CDS982637L ;  27) VASCULAR TRAUMA , Pack Number CDS982641K ;  28) AV FISTULA CDS, Pack Number CDS982660G ;  29) AV FISTULA CDS, Pack Number CDS982660I ;  30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ;  31) AV FISTULA/ACCESS , Pack Number CDS983060I ;  32) AV FISTULA/ACCESS , Pack Number CDS983060J ;  33) AV SHUNT CDS, Pack Number CDS983098B ;  34) AV SHUNT CDS, Pack Number CDS983098C ;  35) VASCULAR ACCESS CDS , Pack Number CDS983105C ;  36) VP SHUNT, Pack Number CDS983366K ;  37) VP SHUNT, Pack Number CDS983366L ;  38) AV FISTULA, Pack Number CDS983638G ;  39) AV FISTULA, Pack Number CDS983638I ;  40) AV FISTULA, Pack Number CDS983638J ;  41) BARIATRIC CDS , Pack Number CDS983657J ;  42) BARIATRIC CDS , Pack Number CDS983657K ;  43) BARIATRIC CDS , Pack Number CDS983883C ;  44) GROTH AV FISTULA CDS, Pack Number CDS984191P ;  45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ;  46) GROTH AV FISTULA CDS, Pack Number CDS984191S ;  47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ;  48) GROTH LASER VEIN, Pack Number CDS984193R;  49) SHY AV FISTULA CDS, Pack Number CDS984512G ;  50) AV FISTULA, Pack Number CDS985510G ;  51) THORACOSTOMY TRAY , Pack Number CHT2010;  52) TRAUMA CHEST TUBE SET , Pack Number CHT2015;  53) BARD MYPICC$ KIT, Pack Number CK000234A;  54) BARD MYPICC$ KIT, Pack Number CK000236A;  55) BARD MYPICC$ KIT, Pack Number CK000324 ;  56) BARD MYPICC$ KIT, Pack Number CK000325 ;  57) BARD MYPICC$ KIT, Pack Number CK000645A;  58) BARD MYPICC$ KIT, Pack Number CK000646A;  59) BARD MYPICC$ KIT, Pack Number CK000647A;  60) BARD MYPICC$ KIT, Pack Number CK000713 ;  61) BARD MYPICC$ KIT, Pack Number CK000714 ;  62) CENTRAL LINE TRAY , Pack Number CVI4705;  63) CVC INSERTION PACK, Pack Number CVI4720;  64) ****, Pack Number CVI4720B ;  65) KIT LINE INSERTION, Pack Number CVI4730;  66) KIT LINE INSERTION, Pack Number CVI4730A ;  67) VENOUS ACCESS TRAY, Pack Number CVI4830B ;  68) PORT INSERTION PACK , Pack Number CVI4870;  69) MVHS CVC LUMEN TRAY , Pack Number CVI4920;  70) NO CATHETER BUNDLE, Pack Number CVI4925A ;  71) UAMS PORT INSERTION KIT , Pack Number CVI5040;  72) CVL INSERTION PACK, Pack Number CVI5065;  73) CVL INSERTION PACK, Pack Number CVI5065H ;  74) HEMODIALYSIS TRAY , Pack Number DT8800 ;  75) ERCP KIT, Pack Number DYKE1006A;  76) PULMONARY KIT , Pack Number DYKE1870 ;  77) PULMONARY KIT, Pack Number DYKE1870H;  78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A;  79) ULTRASOUND PACK , Pack Number DYNDA1249A ;  80) CT SCAN-TC, Pack Number DYNDA1380A ;  81) CT SCAN-TC, Pack Number DYNDA1380AH;  82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077;  83) BAL KIT , Pack Number DYNDA2137B ;  84) STERILE PRE OP PACK , Pack Number (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-2997-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) PUNCTURE TRAY , Pack Number 00-401649G ;  2) PICC LINE TRAY, Pack Number 00-401993O ;  3) ARTERIOGRAM TRAY, Pack Number 00-402001T ;  4) ARTERIOGRAM TRAY, Pack Number 00-402001U ;  5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;  6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ;  7) AV FISTULA PACK , Pack Number CDS840188M ;  8) VP SHUNT, Pack Number CDS840193V ;  9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ;  10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ;  11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH;  12) CENTRAL LINE CDS, Pack Number CDS930092V ;  13) CENTRAL LINE CDS, Pack Number CDS930092W ;  14) CENTRAL LINE CDS, Pack Number CDS930092X ;  15) C LINE INSERTION CDS, Pack Number CDS980379I ;  16) C LINE INSERTION CDS, Pack Number CDS980379J ;  17) AV FISTULA - SMH, Pack Number CDS980916L ;  18) AV FISTULA CDS, Pack Number CDS981513G ;  19) VASCULAR ACCESS CDS , Pack Number CDS981552F ;  20) VP SHUNT CDS, Pack Number CDS981740G ;  21) VP SHUNT CDS, Pack Number CDS981740I ;  22) PORT A CATH , Pack Number CDS982047Q ;  23) SHY VP SHUNT CDS, Pack Number CDS982389J;  24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ;  25) A-V FISTULA , Pack Number CDS982637K ;  26) A-V FISTULA , Pack Number CDS982637L ;  27) VASCULAR TRAUMA , Pack Number CDS982641K ;  28) AV FISTULA CDS, Pack Number CDS982660G ;  29) AV FISTULA CDS, Pack Number CDS982660I ;  30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ;  31) AV FISTULA/ACCESS , Pack Number CDS983060I ;  32) AV FISTULA/ACCESS , Pack Number CDS983060J ;  33) AV SHUNT CDS, Pack Number CDS983098B ;  34) AV SHUNT CDS, Pack Number CDS983098C ;  35) VASCULAR ACCESS CDS , Pack Number CDS983105C ;  36) VP SHUNT, Pack Number CDS983366K ;  37) VP SHUNT, Pack Number CDS983366L ;  38) AV FISTULA, Pack Number CDS983638G ;  39) AV FISTULA, Pack Number CDS983638I ;  40) AV FISTULA, Pack Number CDS983638J ;  41) BARIATRIC CDS , Pack Number CDS983657J ;  42) BARIATRIC CDS , Pack Number CDS983657K ;  43) BARIATRIC CDS , Pack Number CDS983883C ;  44) GROTH AV FISTULA CDS, Pack Number CDS984191P ;  45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ;  46) GROTH AV FISTULA CDS, Pack Number CDS984191S ;  47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ;  48) GROTH LASER VEIN, Pack Number CDS984193R;  49) SHY AV FISTULA CDS, Pack Number CDS984512G ;  50) AV FISTULA, Pack Number CDS985510G ;  51) THORACOSTOMY TRAY , Pack Number CHT2010;  52) TRAUMA CHEST TUBE SET , Pack Number CHT2015;  53) BARD MYPICC$ KIT, Pack Number CK000234A;  54) BARD MYPICC$ KIT, Pack Number CK000236A;  55) BARD MYPICC$ KIT, Pack Number CK000324 ;  56) BARD MYPICC$ KIT, Pack Number CK000325 ;  57) BARD MYPICC$ KIT, Pack Number CK000645A;  58) BARD MYPICC$ KIT, Pack Number CK000646A;  59) BARD MYPICC$ KIT, Pack Number CK000647A;  60) BARD MYPICC$ KIT, Pack Number CK000713 ;  61) BARD MYPICC$ KIT, Pack Number CK000714 ;  62) CENTRAL LINE TRAY , Pack Number CVI4705;  63) CVC INSERTION PACK, Pack Number CVI4720;  64) ****, Pack Number CVI4720B ;  65) KIT LINE INSERTION, Pack Number CVI4730;  66) KIT LINE INSERTION, Pack Number CVI4730A ;  67) VENOUS ACCESS TRAY, Pack Number CVI4830B ;  68) PORT INSERTION PACK , Pack Number CVI4870;  69) MVHS CVC LUMEN TRAY , Pack Number CVI4920;  70) NO CATHETER BUNDLE, Pack Number CVI4925A ;  71) UAMS PORT INSERTION KIT , Pack Number CVI5040;  72) CVL INSERTION PACK, Pack Number CVI5065;  73) CVL INSERTION PACK, Pack Number CVI5065H ;  74) HEMODIALYSIS TRAY , Pack Number DT8800 ;  75) ERCP KIT, Pack Number DYKE1006A;  76) PULMONARY KIT , Pack Number DYKE1870 ;  77) PULMONARY KIT, Pack Number DYKE1870H;  78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A;  79) ULTRASOUND PACK , Pack Number DYNDA1249A ;  80) CT SCAN-TC, Pack Number DYNDA1380A ;  81) CT SCAN-TC, Pack Number DYNDA1380AH;  82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077;  83) BAL KIT , Pack Number DYNDA2137B ;  84) STERILE PRE OP PACK , Pack Number",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2997-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2997-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) PUNCTURE TRAY , Pack Number 00-401649G ;  2) PICC LINE TRAY, Pack Number 00-401993O ;  3) ARTERIOGRAM TRAY, Pack Number 00-402001T ;  4) ARTERIOGRAM TRAY, Pack Number 00-402001U ;  5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;  6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ;  7) AV FISTULA PACK , Pack Number CDS840188M ;  8) VP SHUNT, Pack Number CDS840193V ;  9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ;  10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ;  11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH;  12) CENTRAL LINE CDS, Pack Number CDS930092V ;  13) CENTRAL LINE CDS, Pack Number CDS930092W ;  14) CENTRAL LINE CDS, Pack Number CDS930092X ;  15) C LINE INSERTION CDS, Pack Number CDS980379I ;  16) C LINE INSERTION CDS, Pack Number CDS980379J ;  17) AV FISTULA - SMH, Pack Number CDS980916L ;  18) AV FISTULA CDS, Pack Number CDS981513G ;  19) VASCULAR ACCESS CDS , Pack Number CDS981552F ;  20) VP SHUNT CDS, Pack Number CDS981740G ;  21) VP SHUNT CDS, Pack Number CDS981740I ;  22) PORT A CATH , Pack Number CDS982047Q ;  23) SHY VP SHUNT CDS, Pack Number CDS982389J;  24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ;  25) A-V FISTULA , Pack Number CDS982637K ;  26) A-V FISTULA , Pack Number CDS982637L ;  27) VASCULAR TRAUMA , Pack Number CDS982641K ;  28) AV FISTULA CDS, Pack Number CDS982660G ;  29) AV FISTULA CDS, Pack Number CDS982660I ;  30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ;  31) AV FISTULA/ACCESS , Pack Number CDS983060I ;  32) AV FISTULA/ACCESS , Pack Number CDS983060J ;  33) AV SHUNT CDS, Pack Number CDS983098B ;  34) AV SHUNT CDS, Pack Number CDS983098C ;  35) VASCULAR ACCESS CDS , Pack Number CDS983105C ;  36) VP SHUNT, Pack Number CDS983366K ;  37) VP SHUNT, Pack Number CDS983366L ;  38) AV FISTULA, Pack Number CDS983638G ;  39) AV FISTULA, Pack Number CDS983638I ;  40) AV FISTULA, Pack Number CDS983638J ;  41) BARIATRIC CDS , Pack Number CDS983657J ;  42) BARIATRIC CDS , Pack Number CDS983657K ;  43) BARIATRIC CDS , Pack Number CDS983883C ;  44) GROTH AV FISTULA CDS, Pack Number CDS984191P ;  45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ;  46) GROTH AV FISTULA CDS, Pack Number CDS984191S ;  47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ;  48) GROTH LASER VEIN, Pack Number CDS984193R;  49) SHY AV FISTULA CDS, Pack Number CDS984512G ;  50) AV FISTULA, Pack Number CDS985510G ;  51) THORACOSTOMY TRAY , Pack Number CHT2010;  52) TRAUMA CHEST TUBE SET , Pack Number CHT2015;  53) BARD MYPICC$ KIT, Pack Number CK000234A;  54) BARD MYPICC$ KIT, Pack Number CK000236A;  55) BARD MYPICC$ KIT, Pack Number CK000324 ;  56) BARD MYPICC$ KIT, Pack Number CK000325 ;  57) BARD MYPICC$ KIT, Pack Number CK000645A;  58) BARD MYPICC$ KIT, Pack Number CK000646A;  59) BARD MYPICC$ KIT, Pack Number CK000647A;  60) BARD MYPICC$ KIT, Pack Number CK000713 ;  61) BARD MYPICC$ KIT, Pack Number CK000714 ;  62) CENTRAL LINE TRAY , Pack Number CVI4705;  63) CVC INSERTION PACK, Pack Number CVI4720;  64) ****, Pack Number CVI4720B ;  65) KIT LINE INSERTION, Pack Number CVI4730;  66) KIT LINE INSERTION, Pack Number CVI4730A ;  67) VENOUS ACCESS TRAY, Pack Number CVI4830B ;  68) PORT INSERTION PACK , Pack Number CVI4870;  69) MVHS CVC LUMEN TRAY , Pack Number CVI4920;  70) NO CATHETER BUNDLE, Pack Number CVI4925A ;  71) UAMS PORT INSERTION KIT , Pack Number CVI5040;  72) CVL INSERTION PACK, Pack Number CVI5065;  73) CVL INSERTION PACK, Pack Number CVI5065H ;  74) HEMODIALYSIS TRAY , Pack Number DT8800 ;  75) ERCP KIT, Pack Number DYKE1006A;  76) PULMONARY KIT , Pack Number DYKE1870 ;  77) PULMONARY KIT, Pack Number DYKE1870H;  78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A;  79) ULTRASOUND PACK , Pack Number DYNDA1249A ;  80) CT SCAN-TC, Pack Number DYNDA1380A ;  81) CT SCAN-TC, Pack Number DYNDA1380AH;  82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077;  83) BAL KIT , Pack Number DYNDA2137B ;  84) STERILE PRE OP PACK , Pack Number",
      "text": "The FDA logged enforcement record Z-2997-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) PUNCTURE TRAY , Pack Number 00-401649G ;  2) PICC LINE TRAY, Pack Number 00-401993O ;  3) ARTERIOGRAM TRAY, Pack Number 00-402001T ;  4) ARTERIOGRAM TRAY, Pack Number 00-402001U ;  5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;  6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ;  7) AV FISTULA PACK , Pack Number CDS840188M ;  8) VP SHUNT, Pack Number CDS840193V ;  9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ;  10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ;  11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH;  12) CENTRAL LINE CDS, Pack Number CDS930092V ;  13) CENTRAL LINE CDS, Pack Number CDS930092W ;  14) CENTRAL LINE CDS, Pack Number CDS930092X ;  15) C LINE INSERTION CDS, Pack Number CDS980379I ;  16) C LINE INSERTION CDS, Pack Number CDS980379J ;  17) AV FISTULA - SMH, Pack Number CDS980916L ;  18) AV FISTULA CDS, Pack Number CDS981513G ;  19) VASCULAR ACCESS CDS , Pack Number CDS981552F ;  20) VP SHUNT CDS, Pack Number CDS981740G ;  21) VP SHUNT CDS, Pack Number CDS981740I ;  22) PORT A CATH , Pack Number CDS982047Q ;  23) SHY VP SHUNT CDS, Pack Number CDS982389J;  24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ;  25) A-V FISTULA , Pack Number CDS982637K ;  26) A-V FISTULA , Pack Number CDS982637L ;  27) VASCULAR TRAUMA , Pack Number CDS982641K ;  28) AV FISTULA CDS, Pack Number CDS982660G ;  29) AV FISTULA CDS, Pack Number CDS982660I ;  30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ;  31) AV FISTULA/ACCESS , Pack Number CDS983060I ;  32) AV FISTULA/ACCESS , Pack Number CDS983060J ;  33) AV SHUNT CDS, Pack Number CDS983098B ;  34) AV SHUNT CDS, Pack Number CDS983098C ;  35) VASCULAR ACCESS CDS , Pack Number CDS983105C ;  36) VP SHUNT, Pack Number CDS983366K ;  37) VP SHUNT, Pack Number CDS983366L ;  38) AV FISTULA, Pack Number CDS983638G ;  39) AV FISTULA, Pack Number CDS983638I ;  40) AV FISTULA, Pack Number CDS983638J ;  41) BARIATRIC CDS , Pack Number CDS983657J ;  42) BARIATRIC CDS , Pack Number CDS983657K ;  43) BARIATRIC CDS , Pack Number CDS983883C ;  44) GROTH AV FISTULA CDS, Pack Number CDS984191P ;  45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ;  46) GROTH AV FISTULA CDS, Pack Number CDS984191S ;  47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ;  48) GROTH LASER VEIN, Pack Number CDS984193R;  49) SHY AV FISTULA CDS, Pack Number CDS984512G ;  50) AV FISTULA, Pack Number CDS985510G ;  51) THORACOSTOMY TRAY , Pack Number CHT2010;  52) TRAUMA CHEST TUBE SET , Pack Number CHT2015;  53) BARD MYPICC$ KIT, Pack Number CK000234A;  54) BARD MYPICC$ KIT, Pack Number CK000236A;  55) BARD MYPICC$ KIT, Pack Number CK000324 ;  56) BARD MYPICC$ KIT, Pack Number CK000325 ;  57) BARD MYPICC$ KIT, Pack Number CK000645A;  58) BARD MYPICC$ KIT, Pack Number CK000646A;  59) BARD MYPICC$ KIT, Pack Number CK000647A;  60) BARD MYPICC$ KIT, Pack Number CK000713 ;  61) BARD MYPICC$ KIT, Pack Number CK000714 ;  62) CENTRAL LINE TRAY , Pack Number CVI4705;  63) CVC INSERTION PACK, Pack Number CVI4720;  64) ****, Pack Number CVI4720B ;  65) KIT LINE INSERTION, Pack Number CVI4730;  66) KIT LINE INSERTION, Pack Number CVI4730A ;  67) VENOUS ACCESS TRAY, Pack Number CVI4830B ;  68) PORT INSERTION PACK , Pack Number CVI4870;  69) MVHS CVC LUMEN TRAY , Pack Number CVI4920;  70) NO CATHETER BUNDLE, Pack Number CVI4925A ;  71) UAMS PORT INSERTION KIT , Pack Number CVI5040;  72) CVL INSERTION PACK, Pack Number CVI5065;  73) CVL INSERTION PACK, Pack Number CVI5065H ;  74) HEMODIALYSIS TRAY , Pack Number DT8800 ;  75) ERCP KIT, Pack Number DYKE1006A;  76) PULMONARY KIT , Pack Number DYKE1870 ;  77) PULMONARY KIT, Pack Number DYKE1870H;  78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A;  79) ULTRASOUND PACK , Pack Number DYNDA1249A ;  80) CT SCAN-TC, Pack Number DYNDA1380A ;  81) CT SCAN-TC, Pack Number DYNDA1380AH;  82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077;  83) BAL KIT , Pack Number DYNDA2137B ;  84) STERILE PRE OP PACK , Pack Number — 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: 00-401649G , Lot Number 19IMB453 ;  00-401649G , Lot Number 19KMA787 ;  00-401649G , Lot Number 19LMC950 ;  00-401649G , Lot Number 20EMA317 ;  00-401649G , Lot Number 20EMC074 ;  00-401649G , Lot Number 20HMA234 ;  00-401649G , Lot Number 20JME695 ;  00-401649G , Lot Number 20LME609 ;  00-401649G , Lot Number 21BME658 ;  00-401649G , Lot Number 21CMB025 ;  00-401649G , Lot Number 21CMD185 ;  00-401649G , Lot Number 21DMA102 ;  00-401649G , Lot Number 21JMA649 ;  00-401649G , Lot Number 21JMF121 ;  00-401649G , Lot Number 19BKC121 ;  00-401649G , Lot Number 19CKD014 ;  00-401649G , Lot Number 19EKA045 ;  00-401649G , Lot Number 19GKA016 ;  00-401649G , Lot Number 19HKB535 ;  00-401649G , Lot Number 19IKB266 ;  00-401993O , Lot Number 23JBF090 ;  00-401993O , Lot Number 23KBH528 ;  00-401993O , Lot Number 23LBO811 ;  00-402001T , Lot Number 21GBL509 ;  00-402001T , Lot Number 21JBN647 ;  00-402001T , Lot Number 21JBZ697 ;  00-402001T , Lot Number 22BBX248 ;  00-402001T , Lot Number 22DBL467 ;  00-402001T , Lot Number 22DBS962 ;  00-402001T , Lot Number 22GBC939 ;  00-402001T , Lot Number 22HBO291 ;  00-402001T , Lot Number 22HBO322 ;  00-402001T , Lot Number 22IBN444 ;  00-402001T , Lot Number 22IBO023 ;  00-402001T , Lot Number 22KBT315 ;  00-402001T , Lot Number 23BBA151 ;  00-402001T , Lot Number 23CBI235 ;  00-402001T , Lot Number 23DBM140 ;  00-402001T , Lot Number 23EBT729 ;  00-402001T , Lot Number 23GBR995 ;  00-402001T , Lot Number 23GBS336 ;  00-402001U , Lot Number 23JBU819 ;  00-402001U , Lot Number 23LBG449 ;  A134-MAX , Lot Number 19BKA379 ;  A134-MAX , Lot Number 19DKB704 ;  A134-MAX , Lot Number 19HKA891 ;  A134-MAX , Lot Number 19KKA912 ;  A134-MAX , Lot Number 19KKB286 ;  A134-MAX , Lot Number 19KKB345 ;  A134-MAX , Lot Number 20BKA796 ;  A134-MAX , Lot Number 20EKA291 ;  A134-MAX , Lot Number 20FKA121 ;  A134-MAX , Lot Number 20FKB492 ;  ARTNC175 , Lot Number 24AMF171 ;  CDS840188M , Lot Number 21GME281 ;  CDS840188M , Lot Number 21HMG887 ;  CDS840188M , Lot Number 21LMG878 ;  CDS840188M , Lot Number 22DMC877 ;  CDS840188M , Lot Number 22FMF061 ;  CDS840188M , Lot Number 22HMA885 ;  CDS840188M , Lot Number 22HMG503 ;  CDS840188M , Lot Number 22LMC521 ;  CDS840188M , Lot Number 23JMC244 ;  CDS840188M , Lot Number 23LMH857 ;  CDS840188M , Lot Number 19DKC523 ;  CDS840188M , Lot Number 19FKB927 ;  CDS840188M , Lot Number 19GKC786 ;  CDS840188M , Lot Number 19IKA428 ;  CDS840188M , Lot Number 19LKB624 ;  CDS840188M , Lot Number 20CKA278 ;  CDS840188M , Lot Number 20EKB674 ;  CDS840188M , Lot Number 20GKA668 ;  CDS840188M , Lot Number 20IKA403 ;  CDS840188M , Lot Number 20LKB098 ;  CDS840188M , Lot Number 21CKA368 ;  CDS840193V , Lot Number 21HBE520 ;  CDS840193V , Lot Number 21HBE521 ;  CDS840193V , Lot Number 21HBH244 ;  CDS840193V , Lot Number 21JBE527 ;  CDS840193V , Lot Number 21KBE066 ;  CDS840193V , Lot Number 22ABM907 ;  CDS840193V , Lot Number 22MBA145 ;  CDS840193V , Lot Number 22DBP331 ;  CDS840193V , Lot Number 22EBM213 ;  CDS840193V , Lot Number 22EBN031 ;  CDS840193V , Lot Number 22EBR456 ;  CDS840193V , Lot Number 22GBU281 ;  CDS840193V , Lot Number 23DBO524 ;  CDS840193V , Lot Number 23EBW686 ;  CDS840193V , Lot Number 23FBO564 ;  CDS840193V , Lot Number 23IBQ501 ;  CDS840193V , Lot Number 23JBD094 ;  CDS840193V , Lot Number 23JBW804 ;  CDS840193V , Lot Number 23JBX015 ;  CDS840193V , Lot Number 21FBC630 ;  CDS840295G , Lot Number 21FBN182 ;  CDS840295G , Lot Number 21HBB477 ;  CDS840295G , Lot Number 21HBB479 ;  CDS840295G , Lot Number 21IBK120 ;  CDS840295G , Lot Number 21JBU314 ;  CDS840295G , Lot Number 21LBO663 ;  CDS840295G , Lot Number 22OBI226 ;  CDS840295G , Lot Number 22OBL670 ;  CDS840295G , Lot Number 22GBA989 ;  CDS840295G , Lot Number 22GBA991 ;  CDS840295G , Lot Number 22GBA994 ;  CDS840295G , Lot Number 19RBD411 ;  CDS840295G , Lot Number 22HBQ573 ;  CDS840295G , Lot Number 22IBE716 ;  CDS840295G , Lot Number 19IBD862 ;  CDS840295G , Lot Number 19IBJ104 ;  CDS840295G , Lot Number 19VBC474 ;  CDS840295G , Lot Number 19WBA922 ;  CDS840295G , Lot Number 20ABS649 ;  CDS840295G , Lot Number 20BBE304 ;  CDS840295G , Lot Number 20BBZ155 ;  CDS840295G , Lot Number 20EBG194 ;  CDS840295G , Lot Number 20FBV524 ;  CDS840295G , Lot Number 20HBC285 ;  CDS840295G , Lot Number 20JBH402 ;  CDS840295G , Lot Number 21BBA694 ;  CDS840295G , Lot Number 21BBE943 ;  CDS840295G , Lot Number 21BBG966 ;  CDS840295G , Lot Number 21DBG123 ;  CDS860033A , Lot Number 22ABT263 ;  CDS860033A , Lot Number 22BBM414 ;  CDS860033A , Lot Number 19ABO084 ;  CDS860033A , Lot Number 19ABV178 ;  CDS860033A , Lot Number 19BBD349 ;  CDS860033A , Lot Number 19CBL856 ;  CDS860033A , Lot Number 22DBN148 ;  CDS860033A , Lot Number 19DBJ620 ;  CDS860033A , Lot Number 22FBW038 ;  CDS860033A , Lot Number 22GBT020 ;  CDS860033A , Lot Number 19HBB212 ;  CDS860033A , Lot Number 22JBI775 ;  CDS860033A , Lot Number 19TBB915 ;  CDS860033A , Lot Number 22KBO931 ;  CDS860033A , Lot Number 19JBJ664 ;  CDS860033A , Lot Number 23ABH649 ;  CDS860033A , Lot Number 23BBH056 ;  CDS860033A , Lot Number 20BBJ471 ;  CDS860033A , Lot Number 20BBM839 ;  CDS860033A , Lot Number 20CBA321 ;  CDS860033A , Lot Number 23FBT671 ;  CDS860033A , Lot Number 23GBT005 ;  CDS860033A , Lot Number 23HBC058 ;  CDS860033A , Lot Number 20EBA004 ;  CDS860033A , Lot Number 23HBV413 ;  CDS860033A , Lot Number 20EBC143 ;  CDS860033A , Lot Number 23JBI052 ;  CDS860033A , Lot Number 20HBA540 ;  CDS860033A , Lot Number 23KBV897 ;  CDS860033A , Lot Number 20IBE893 ;  CDS860033A , Lot Number 20IBG071 ;  CDS860033A , Lot Number 24ABX646 ;  CDS860033A , Lot Number 20JBS964 ;  CDS860033A , Lot Number 20KBE285 ;  CDS860033A , Lot Number 20LBU734 ;  CDS860033A , Lot Number 21ABQ647 ;  CDS860033A , Lot Number 21BBA695 ;  CDS860033A , Lot Number 21BBJ404 ;  CDS860033A , Lot Number 21BBO991 ;  CDS860033A , Lot Number 21CBW001 ;  CDS860033AH, Lot Number 22ABT263 ;  CDS860033AH, Lot Number 22BBM414 ;  CDS860033AH, Lot Number 19ABO084 ;  CDS860033AH, Lot Number 19ABV178 ;  CDS860033AH, Lot Number 19BBD349 ;  CDS860033AH, Lot Number 19CBL856 ;  CDS860033AH, Lot Number 22DBN148 ;  CDS860033AH, Lot Number 19DBJ620 ;  CDS860033AH, Lot Number 22FBW038 ;  CDS860033AH, Lot Number 22GBT020 ;  CDS860033AH, Lot Number 19HBB212 ;  CDS860033AH, Lot Number 22JBI775 ;  CDS860033AH, Lot Number 19TBB915 ;  CDS860033AH, Lot Number 22KBO931 ;  CDS860033AH, Lot Number 19JBJ664 ;  CDS860033AH, Lot Number 23ABH649 ;  CDS860033AH, Lot Number 23BBH056 ;  CDS860033AH, Lot Number 23FBT671 ;  CDS860033AH, Lot Number 23GBT005 ;  CDS860033AH, Lot Number 23HBC058 ;  CDS860033AH, Lot Number 23HBV413 ;  CDS860033AH, Lot Number 23JBI052 ;  CDS860033AH, Lot Number 23KBV897 ;  CDS860033AH, Lot Number 24ABX646 ;  CDS860033AH, Lot Number 21ABQ647 ;  CDS860033AH, Lot Number 21BBA695 ;  CDS860033AH, Lot Number 21BBJ404 ;  CDS860033AH, Lot Number 21BBO991 ;  CDS860033AH, Lot Number 21CBW001 ;  CDS930092V , Lot Number 21BBB761 ;  CDS930092V , Lot Number 21BBQ623 ;  CDS930092W , Lot Number 21FBP631 ;  CDS930092W , Lot Number 21GBV735 ;  CDS930092W , Lot Number 21GBV736 ;  CDS930092W , Lot Number 21IBE940 ;  CDS930092W , Lot Number 21IBW823 ;  CDS930092W , Lot Number 21JBU301 ;  CDS930092W , Lot Number 22ABD356 ;  CDS930092W , Lot Number 22OBB410 ;  CDS930092W , Lot Number 22DBA742 ;  CDS930092W , Lot Number 22FBS189 ;  CDS930092W , Lot Number 21DBQ816 ;  CDS930092X , Lot Number 22HBT776 ;  CDS930092X , Lot Number 22HBU263 ;  CDS930092X , Lot Number 22KBI026 ;  CDS930092X , Lot Number 22KBI831 ;  CDS930092X , Lot Number 23ABC352 ;  CDS930092X , Lot Number 23CBX277 ;  CDS930092X , Lot Number 23EBF083 ;  CDS930092X , Lot Number 23EBL945 ;  CDS930092X , Lot Number 23FBI837 ;  CDS930092X , Lot Number 23HBO380 ;  CDS930092X , Lot Number 23IBE351 ;  CDS930092X , Lot Number 23IBN415 ;  CDS930092X , Lot Number 23JBU793 ;  CDS930092X , Lot Number 23KBW573 ;  CDS930092X , Lot Number 24CBA853 ;  CDS980379I , Lot Number 21JBA033 ;  CDS980379I , Lot Number 21KBU590 ;  CDS980379J , Lot Number 22ABD360 ;  CDS980379J , Lot Number 22BBM228 ;  CDS980379J , Lot Number 22EBS480 ;  CDS980379J , Lot Number 22FBO274 ;  CDS980379J , Lot Number 22GBZ054 ;  CDS980379J , Lot Number 22IBC654 ;  CDS980379J , Lot Number 22LBM746 ;  CDS980379J , Lot Number 23ABB770 ;  CDS980379J , Lot Number 23ABP535 ;  CDS980379J , Lot Number 23EBC764 ;  CDS980379J , Lot Number 23FBH022 ;  CDS980379J , Lot Number 23HBD740 ;  CDS980379J , Lot Number 23IBQ696 ;  CDS980379J , Lot Number 23LBS839 ;  CDS980379J , Lot Number 24BBE041 ;  CDS980916L , Lot Number 21EBC082 ;  CDS981513G , Lot Number 19FDB661 ;  CDS981513G , Lot Number 19HDB466 ;  CDS981513G , Lot Number 19IDA123 ;  CDS981513G , Lot Number 19KDC365 ;  CDS981513G , Lot Number 20GDA307 ;  CDS981513G , Lot Number 20GDA958 ;  CDS981513G , Lot Number 20IDA174 ;  CDS981513G , Lot Number 20IDA815 ;  CDS981513G , Lot Number 20IDB447 ;  CDS981513G , Lot Number 21ADA966 ;  CDS981513G , Lot Number 21LDC079 ;  CDS981552F , Lot Number 21FBL049 ;  CDS981552F , Lot Number 19BBN799 ;  CDS981552F , Lot Number 19CBQ567 ;  CDS981552F , Lot Number 19DBG524 ;  CDS981552F , Lot Number 19FBW511 ;  CDS981552F , Lot Number 19GBS783 ;  CDS981552F , Lot Number 19HBU781 ;  CDS981552F , Lot Number 20DBD797 ;  CDS981552F , Lot Number 20FBB152 ;  CDS981552F , Lot Number 20FBM682 ;  CDS981552F , Lot Number 20JBO798 ;  CDS981552F , Lot Number 21BBG842 ;  CDS981552F , Lot Number 21DBJ790 ;  CDS981552F , Lot Number 21EBI549 ;  CDS981740G , Lot Number 19JBT846 ;  CDS981740G , Lot Number 20ABE322 ;  CDS981740G , Lot Number 20BBE594 ;  CDS981740G , Lot Number 20DBF870 ;  CDS981740G , Lot Number 20FBC072 ;  CDS981740G , Lot Number 20HBC683 ;  CDS981740G , Lot Number 20HBP054 ;  CDS981740G , Lot Number 20HBQ757 ;  CDS981740G , Lot Number 20JBQ386 ;  CDS981740G , Lot Number 20LBL345 ;  CDS981740G , Lot Number 20LBV734 ;  CDS981740G , Lot Number 20LBW877 ;  CDS981740I , Lot Number 21FBO491 ;  CDS981740I , Lot Number 21GBJ341 ;  CDS981740I , Lot Number 21IBT665 ;  CDS981740I , Lot Number 21KBI181 ;  CDS981740I , Lot Number 21LBB435 ;  CDS981740I , Lot Number 21LBO595 ;  CDS981740I , Lot Number 21LBO596 ;  CDS981740I , Lot Number 22NBA990 ;  CDS981740I , Lot Number 22CBV017 ;  CDS981740I , Lot Number 22DBD191 ;  CDS981740I , Lot Number 22DBG800 ;  CDS981740I , Lot Number 22DBS548 ;  CDS981740I , Lot Number 22EBK721 ;  CDS981740I , Lot Number 22GBA960 ;  CDS981740I , Lot Number 22HBF409 ;  CDS981740I , Lot Number 21CBV552 ;  CDS982047Q , Lot Number 21JDC632 ;  CDS982047Q , Lot Number 21LDB376 ;  CDS982047Q , Lot Number 22BDC332 ;  CDS982047Q , Lot Number 22DDB499 ;  CDS982047Q , Lot Number 22GDA026 ;  CDS982047Q , Lot Number 22GDB948 ;  CDS982047Q , Lot Number 22IDA166 ;  CDS982047Q , Lot Number 22KDA648 ;  CDS982047Q , Lot Number 23ADB084 ;  CDS982047Q , Lot Number 23CDB665 ;  CDS982047Q , Lot Number 23DDB432 ;  CDS982047Q , Lot Number 23FDB743 ;  CDS982047Q , Lot Number 23HDC294 ;  CDS982047Q , Lot Number 23KDC271 ;  CDS982389J, Lot Number 22IBU058;  CDS982389J, Lot Number 22HBH306;  CDS982389J, Lot Number 22GBQ912; 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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
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      "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-2997-2024&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-2997-2024&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-2997-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2997-2024 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",
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        "adjudged": true,
        "operative": true
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      "grounding": {
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        "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-2997-2024&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-2997-2024&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-2997-2024/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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        "adjudged": false,
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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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            "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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 CDS860033AH, Lot Number 19CBL856 ;  CDS860033AH, Lot Number 22DBN148 ;  CDS860033AH, Lot Number 19DBJ620 ;  CDS860033AH, Lot Number 22FBW038 ;  CDS860033AH, Lot Number 22GBT020 ;  CDS860033AH, Lot Number 19HBB212 ;  CDS860033AH, Lot Number 22JBI775 ;  CDS860033AH, Lot Number 19TBB915 ;  CDS860033AH, Lot Number 22KBO931 ;  CDS860033AH, Lot Number 19JBJ664 ;  CDS860033AH, Lot Number 23ABH649 ;  CDS860033AH, Lot Number 23BBH056 ;  CDS860033AH, Lot Number 23FBT671 ;  CDS860033AH, Lot Number 23GBT005 ;  CDS860033AH, Lot Number 23HBC058 ;  CDS860033AH, Lot Number 23HBV413 ;  CDS860033AH, Lot Number 23JBI052 ;  CDS860033AH, Lot Number 23KBV897 ;  CDS860033AH, Lot Number 24ABX646 ;  CDS860033AH, Lot Number 21ABQ647 ;  CDS860033AH, Lot Number 21BBA695 ;  CDS860033AH, Lot Number 21BBJ404 ;  CDS860033AH, Lot Number 21BBO991 ;  CDS860033AH, Lot Number 21CBW001 ;  CDS930092V , Lot Number 21BBB761 ;  CDS930092V , Lot Number 21BBQ623 ;  CDS930092W , Lot Number 21FBP631 ;  CDS930092W , Lot Number 21GBV735 ; 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 DYNDA1380AH, Lot Number 22LBH109 ;  DYNDA1380AH, Lot Number 23ABF213 ;  DYNDA1380AH, Lot Number 23EBM550 ;  DYNDA1380AH, Lot Number 23FBH621 ;  DYNDA1380AH, Lot Number 23GBC347 ;  DYNDA1380AH, Lot Number 23JBO772 ;  DYNDA1380AH, Lot Number 23KBQ517 ;  DYNDA2077, Lot Number 20IBP657;  DYNDA2137B , Lot Number 23IBT323 ;  DYNDA2654A , Lot Number 22JBM977 ;  DYNDA2654A , Lot Number 22JBU450 ;  DYNDA2654A , Lot Number 22LBN857 ;  DYNDA2654B , Lot Number 22LBK150 ;  DYNDA2654B , Lot Number 23BBD087 ;  DYNDA2654B , Lot Number 23CBN996 ;  DYNDA2654B , Lot Number 23FBM938 ;  DYNDA2654B , Lot Number 23HBW413 ;  DYNDA2654B , Lot Number 23IBS425 ;  DYNDA2654B , Lot Number 23JBB731 ;  DYNDA2736A , Lot Number 21JBR480 ;  DYNDA2743, Lot Number 21GBD536 ;  DYNDA2743, Lot Number 21IBR742 ;  DYNDA2743, Lot Number 21JBR492 ;  DYNDA2743, Lot Number 22ABC083 ;  DYNDA2743, Lot Number 22DBG199 ;  DYNDA2743, Lot Number 22IBT562 ;  DYNDA2743, Lot Number 22LBQ221 ;  DYNDA2743, Lot Number 23CBU790 ;  DYNDA2743, Lot Number 23FBO269 ;  DYNDA2743, Lot Number 23HBP847 ;  DYNDA2743, Lot Number 23KBW261 ;  DYNDA2743, Lot Number 20KBF866 ;  DYNDA2743, Lot Number 20LBV309 ;  DYNDA2743, Lot Number 21CBR854 ;  DYNDA2743, Lot Number 21EBC647 ;  DYNDA2743, Lot Number 21EBG462 ;  DYNDA2759, Lot Number 22JBT428 ;  DYNDA2759, Lot Number 22KBB523 ;  DYNDA2759, Lot Number 22LBS589 ;  DYNDA2759, Lot Number 23ABG086 ;  DYNDA2759, Lot Number 21BBG643 ;  DYNDA2759A , Lot Number 23GBQ402 ;  DYNDA2759A , Lot Number 23GBT108 ;  DYNDA2787A , Lot Number 23HBM205 ;  DYNDA2787A , Lot Number 23JBV971 ;  DYNDA2787A , Lot Number 23KBX493 ;  DYNDA2990, Lot Number 22IBQ467 ;  DYNDA2990, Lot Number 22KBN650 ;  DYNDA2990, Lot Number 23EBK469 ;  DYNDA2990, Lot Number 23EBQ567 ;  DYNDA2990, Lot Number 23HBI808 ;  DYNDA2990, Lot Number 23HBS300 ;  DYNDA2990, Lot Number 23JBW267 ;  DYNDA2990, Lot Number 23IMB381 ;  DYNDA2998H , Lot Number 22KBB005 ;  DYNDA2998H , Lot Number 23BBD525 ;  DYNDA3007, Lot Number 23ABJ955 ;  DYNDA3007, Lot Number 23CBN987 ;  DYNDA3007, Lot Number 23DBR128 ;  DYNDA3007, Lot Number 23EBP059 ;  DYNDA3007, Lot Number 23IBL528 ;  DYNDA3007, Lot Number 23JBY331 ;  DYNDA3007, Lot Number 23LBP542 ;  DYNDA3011AH, Lot Number 23JBG151 ;  DYNDA3011AH, Lot Number 23KBT214 ;  DYNDA3043, Lot Number 23FBR585 ;  DYNDA3043, Lot Number 23JBJ847 ;  DYNDA3043, Lot Number 23KBL940 ;  DYNDA3112, Lot Number 24CMA077;  DYNDC1110A , Lot Number 21JBV516 ;  DYNDC1110AH, Lot Number 21JBV516 ;  DYNDC1318F , Lot Number 23JBI259 ;  DYNDC1960A, Lot Number 2018081350;  DYNDC2057, Lot Number 23JBB732;  DYNDC3129, Lot Number 21HBL665 ;  DYNDC3251, Lot Number 22IBG587 ;  DYNDC3251, Lot Number 22LBK717 ;  DYNDC3251, Lot Number 23CBO992 ;  DYNDC3251, Lot Number 23EBM260 ;  DYNDC3251, Lot Number 23FBJ618 ;  DYNDC3251, Lot Number 23GBW852 ;  DYNDC3251, Lot Number 23HBU309 ;  DYNDC3251, Lot Number 23IBU982 ;  DYNDC3251, Lot Number 23JMB414 ;  DYNDC3251, Lot Number 23LME615 ;  DYNDC3251H , Lot Number 22IBG587 ;  DYNDC3251H , Lot Number 23JMB414 ;  DYNDC3251H , Lot Number 23LME615 ;  DYNDC3251H , Lot Number 22LBK717 ;  DYNDC3251H , Lot Number 23CBO992 ;  DYNDC3251H , Lot Number 23EBM260 ;  DYNDC3251H , Lot Number 23FBJ618 ;  DYNDC3251H , Lot Number 23GBW852 ;  DYNDC3251H , Lot Number 23HBU309 ;  DYNDC3251H , Lot Number 23IBU982 ;  DYNDC3255, Lot Number 23ABD853 ;  DYNDC3255, Lot Number 23FBP898 ;  DYNDC3255, Lot Number 23HBC286 ;  DYNDC3255, Lot Number 23JBD836 ;  DYNDC3255, Lot Number 23KBH344 ;  DYNDC3255, Lot Number 23LBB005 ;  DYNDC3263, Lot Number 22JBE153 ;  DYNDC3263, Lot Number 22KBQ163 ;  DYNDC3263, Lot Number 23ABS362 ;  DYNDC3263, Lot Number 23BBB034 ;  DYNDC3263, Lot Number 23BBU127 ;  DYNDC3263, Lot Number 23EBM517 ;  DYNDC3263, Lot Number 23IBE436 ;  DYNDC3263, Lot Number 23JMJ790 ;  DYNDC3263, Lot Number 23KMB878 ;  DYNDC3263H , Lot Number 22JBE153 ;  DYNDC3263H , Lot Number 23JMJ790 ;  DYNDC3263H , Lot Number 23KMB878 ;  DYNDC3263H , Lot Number 22KBQ163 ;  DYNDC3263H , Lot Number 23ABS362 ;  DYNDC3263H , Lot Number 23BBB034 ;  DYNDC3263H , Lot Number 23BBU127 ;  DYNDC3263H , Lot Number 23EBM517 ;  DYNDC3263H , Lot Number 23IBE436 ;  DYNDH1052A , Lot Number 23BBG409 ;  DYNDH1052A , Lot Number 23EBD688 ;  DYNDH1052A , Lot Number 23HBU300 ;  DYNDH1052A , Lot Number 23JBQ041 ;  DYNDH1123B , Lot Number 21JBT694 ;  DYNDH1123BH, Lot Number 21JBT694 ;  DYNDH1275, Lot Number 21EBQ424;  DYNDH1275, Lot Number 21CBD008;  DYNDH1275, Lot Number 21ABI951;  DYNDH1395A , Lot Number 21JBJ563 ;  DYNDH1395A , Lot Number 21LBO085 ;  DYNDH1395A , Lot Number 22CBY447 ;  DYNDH1395A , Lot Number 22JBI559 ;  DYNDH1395A , Lot Number 22KBV270 ;  DYNDH1395A , Lot Number 19JBN294 ;  DYNDH1395A , Lot Number 23BBP230 ;  DYNDH1395A , Lot Number 20ABX701 ;  DYNDH1395A , Lot Number 23EBT269 ;  DYNDH1395A , Lot Number 23FBM815 ;  DYNDH1395A , Lot Number 23IBA665 ;  DYNDH1395A , Lot Number 23JBN121 ;  DYNDH1395A , Lot Number 23JBN316 ;  DYNDH1395A , Lot Number 20JBZ510 ;  DYNDH1395A , Lot Number 20KBX219 ;  DYNDH1395A , Lot Number 20XBI828 ;  DYNDH1395A , Lot Number 21CBW633 ;  DYNDH1395A , Lot Number 21DBN997 ;  DYNDH1636, Lot Number 23GBO820 ;  DYNDH1636, Lot Number 23GBP897 ;  DYNDH1636, Lot Number 23KBX519 ;  DYNDH1654, Lot Number 21JBM327 ;  DYNDH1654, Lot Number 21JBQ373 ;  DYNDH1707, Lot Number 22EBE237 ;  DYNDH1707, Lot Number 22JBI560 ;  DYNDH1707, Lot Number 23EBU407 ;  DYNDH1707, Lot Number 23FBF407 ;  DYNDH1818, Lot Number 23AMH342 ;  DYNDH1818, Lot Number 23DMI187 ;  DYNDH1818, Lot Number 24AMA444 ;  DYNDH1818H , Lot Number 23AMH342 ;  DYNDH1818H , Lot Number 23DMI187 ;  DYNDH1818H , Lot Number 24AMA444 ;  DYNDH1833, Lot Number 23BBG411 ;  DYNDH1833, Lot Number 23DBH315 ;  DYNDH1833, Lot Number 23KBG118 ;  DYNDH1904, Lot Number 23KBN988 ;  DYNDH1905, Lot Number 23JBU154 ;  DYNDH1915, Lot Number 23JBU024 ;  DYNDH1922, Lot Number 23LBD324 ;  DYNDL1508, Lot Number 2022061690;  DYNDL1748, Lot Number 21JBI834 ;  DYNJ00281M , Lot Number 19BBK226 ;  DYNJ00281M , Lot Number 19DBV940 ;  DYNJ00281M , Lot Number 19EBW249 ;  DYNJ00281M , Lot Number 19FBJ668 ;  DYNJ00281M , Lot Number 19JBD521 ;  DYNJ00281M , Lot Number 19JBI229 ;  DYNJ00281M , Lot Number 19VBA470 ;  DYNJ00281M , Lot Number 20HMD357 ;  DYNJ00281M , Lot Number 20IMB300 ;  DYNJ00281M , Lot Number 20JMA297 ;  DYNJ00281O , Lot Number 21GME986 ;  DYNJ00281O , Lot Number 21HMF322 ;  DYNJ00281O , Lot Number 21IMB331 ;  DYNJ00281O , Lot Number 21JMD395 ;  DYNJ00281O , Lot Number 21JMG983 ;  DYNJ00281O , Lot Number 21KMH945 ;  DYNJ00281O , Lot Number 22CMH221 ;  DYNJ00281O , Lot Number 22FMD671 ;  DYNJ00281O , Lot Number 22KMA417 ;  DYNJ00281O , Lot Number 23EMA749 ;  DYNJ00281P, Lot Number 24CMB320;  DYNJ00281P , Lot Number 23GMD333 ;  DYNJ00281P , Lot Number 23HMC426 ;  DYNJ00281P , Lot Number 23JMH441 ;  DYNJ0101291C , Lot Number 19HDA408 ;  DYNJ0101291C , Lot Number 19IDA590 ;  DYNJ0101291C , Lot Number 19JDC821 ;  DYNJ0101291C , Lot Number 20ADB652 ;  DYNJ0101291C , Lot Number 20BDA365 ;  DYNJ0101291C , Lot Number 20CDC635 ;  DYNJ0101291C , Lot Number 20EDA810 ;  DYNJ0101291C , Lot Number 19AKD218 ;  DYNJ0101291C , Lot Number 19CKA581 ;  DYNJ0101291F , Lot Number 22KDB751 ;  DYNJ0101291F , Lot Number 23EDA119 ;  DYNJ0101291F , Lot Number 23EDB388 ;  DYNJ0101291F , Lot Number 23FDA396 ;  DYNJ0101291F , Lot Number 23GDA313 ;  DYNJ0101291F , Lot Number 23HDA759 ;  DYNJ0101291F , Lot Number 23LDB909 ;  DYNJ0117497G , Lot Number 21FBI072 ;  DYNJ0117497G , Lot Number 21GBA846 ;  DYNJ0117497G , Lot Number 21GBE684 ;  DYNJ0117497G , Lot Number 21HBA351 ;  DYNJ0117497G , Lot Number 21IBP593 ;  DYNJ0131782F , Lot Number 20JMC859 ;  DYNJ0131782F , Lot Number 20LMD690 ;  DYNJ0131782F , Lot Number 21CMD799 ;  DYNJ0131782F , Lot Number 21HMC433 ;  DYNJ0131782F , Lot Number 21IMF943 ;  DYNJ0131782F , Lot Number 21JMA367 ;  DYNJ0131782F , Lot Number 21KMB566 ;  DYNJ0131782F , Lot Number 21KMC323 ;  DYNJ0131782F , Lot Number 21LME348 ;  DYNJ0131782F , Lot Number 20FKA867 ;  DYNJ0150250A , Lot Number 19BBO827 ;  DYNJ0150250A , Lot Number 19EBL020 ;  DYNJ0151111C , Lot Number 23DDB304 ;  DYNJ0151111C , Lot Number 23FDC146 ;  DYNJ0151111C , Lot Number 23HDA363 ;  DYNJ0151111C , Lot Number 23IDA769 ;  DYNJ0151111C , Lot Number 23JDB197 ;  DYNJ0151111C , Lot Number 23KDB580 ;  DYNJ0151111C , Lot Number 24BDA016 ;  DYNJ0160348B , Lot Number 19BDC775 ;  DYNJ0160348B , Lot Number 19DDC820 ;  DYNJ0160348B , Lot Number 19KDB134 ;  DYNJ0160348B , Lot Number 20BDB971 ;  DYNJ0160348B , Lot Number 20CDA536 ;  DYNJ0160348B , Lot Number 20CDB453 ;  DYNJ0160348B , Lot Number 20GDA597 ;  DYNJ0160348B , Lot Number 21BDB946 ;  DYNJ0160348B , Lot Number 21HDA843 ;  DYNJ0160348B , Lot Number 21KDA674 ;  DYNJ0160348B , Lot Number 22ADB771 ;  DYNJ0160348B , Lot Number 22EDB536 ;  DYNJ0160348B , Lot Number 22GDA289 ;  DYNJ0160348B , Lot Number 22IDB621 ;  DYNJ0160348B , Lot Number 23HDA183 ;  DYNJ0160348B , Lot Number 23KDC246 ;  DYNJ0161284, Lot Number 23HDC638;  DYNJ0161284, Lot Number 23GDA353;  DYNJ0161284, Lot Number 23FDB695;  DYNJ0161284, Lot Number 22IDC075;  DYNJ0161284, Lot Number 22FDB323;  DYNJ0161284, Lot Number 22EDB436;  DYNJ0161316A , Lot Number 19ADC362 ;  DYNJ0161316A , Lot Number 19BDD339 ;  DYNJ0161316A , Lot Number 19EDB771 ;  DYNJ0161316A , Lot Number 19GDA928 ;  DYNJ0161316A , Lot Number 19HDA271 ;  DYNJ01613",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}