{
  "@context": {
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    "epistemicStatus": "au:epistemicStatus",
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    "grounding": "au:grounding",
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    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
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    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3086-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "smiths medical portex BLUselect, tracheostomy tube, labeled as follows:   1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ;  2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ;  3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ;  4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ;  5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ;  6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ;  7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ;  8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ;  9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ;  10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ;  11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ;  12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ;  13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ;  14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ;  15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ;  16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ;  17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075;  18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ;  19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080;  20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ;  21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ;  22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ;  23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ;  24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ;  25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ;  26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ;  27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ;  28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ;  29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ;  30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ;  31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060;  32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070;  33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075;  34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080;  35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085;  36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090;  37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100;  38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060;  39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070;  40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080;  41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090;  42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100;  43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ;  44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ;  45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ;  46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ;  47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ;  48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ;  49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ;  50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ;  51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ;  52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ;  53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0",
  "description": "FDA recall Z-3086-2024 — Smiths Medical ASD Inc. is recalling smiths medical portex BLUselect, tracheostomy tube, labeled as follows:   1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ;  2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ;  3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ;  4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ;  5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ;  6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ;  7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ;  8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ;  9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ;  10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ;  11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ;  12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ;  13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ;  14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ;  15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ;  16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ;  17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075;  18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ;  19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080;  20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ;  21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ;  22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ;  23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ;  24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ;  25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ;  26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ;  27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ;  28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ;  29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ;  30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ;  31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060;  32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070;  33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075;  34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080;  35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085;  36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090;  37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100;  38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060;  39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070;  40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080;  41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090;  42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100;  43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ;  44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ;  45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ;  46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ;  47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ;  48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ;  49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ;  50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ;  51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ;  52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ;  53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0 (Devices, Class I). 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/",
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  "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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3086-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "smiths medical portex BLUselect, tracheostomy tube, labeled as follows:   1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ;  2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ;  3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ;  4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ;  5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ;  6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ;  7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ;  8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ;  9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ;  10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ;  11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ;  12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ;  13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ;  14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ;  15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ;  16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ;  17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075;  18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ;  19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080;  20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ;  21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ;  22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ;  23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ;  24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ;  25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ;  26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ;  27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ;  28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ;  29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ;  30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ;  31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060;  32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070;  33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075;  34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080;  35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085;  36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090;  37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100;  38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060;  39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070;  40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080;  41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090;  42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100;  43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ;  44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ;  45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ;  46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ;  47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ;  48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ;  49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ;  50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ;  51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ;  52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ;  53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Smiths Medical ASD Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3086-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3086-2024: Smiths Medical ASD Inc. is recalling smiths medical portex BLUselect, tracheostomy tube, labeled as follows:   1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ;  2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ;  3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ;  4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ;  5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ;  6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ;  7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ;  8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ;  9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ;  10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ;  11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ;  12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ;  13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ;  14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ;  15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ;  16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ;  17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075;  18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ;  19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080;  20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ;  21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ;  22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ;  23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ;  24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ;  25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ;  26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ;  27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ;  28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ;  29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ;  30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ;  31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060;  32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070;  33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075;  34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080;  35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085;  36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090;  37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100;  38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060;  39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070;  40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080;  41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090;  42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100;  43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ;  44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ;  45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ;  46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ;  47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ;  48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ;  49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ;  50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ;  51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ;  52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ;  53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0",
      "text": "The FDA logged enforcement record Z-3086-2024: Smiths Medical ASD Inc. is voluntarily recalling smiths medical portex BLUselect, tracheostomy tube, labeled as follows:   1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ;  2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ;  3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ;  4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ;  5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ;  6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ;  7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ;  8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ;  9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ;  10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ;  11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ;  12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ;  13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ;  14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ;  15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ;  16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ;  17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075;  18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ;  19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080;  20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ;  21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ;  22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ;  23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ;  24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ;  25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ;  26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ;  27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ;  28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ;  29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ;  30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ;  31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060;  32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070;  33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075;  34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080;  35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085;  36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090;  37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100;  38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060;  39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070;  40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080;  41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090;  42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100;  43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ;  44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ;  45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ;  46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ;  47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ;  48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ;  49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ;  50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ;  51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ;  52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ;  53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0 — reason: There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-07. Affected lots/codes: 101/800/060CZ, Lot Number 3895097;  101/800/060CZ, Lot Number 3925835;  101/800/060CZ, Lot Number 4025600;  101/800/060CZ, Lot Number 4106716;  101/800/060CZ, Lot Number 4230149;  101/800/060CZ, Lot Number 4252500;  101/800/060CZ, Lot Number 4382002;  101/800/070CZ, Lot Number 3895101;  101/800/070CZ, Lot Number 3925960;  101/800/070CZ, Lot Number 3933088;  101/800/070CZ, Lot Number 4010050;  101/800/070CZ, Lot Number 4022790;  101/800/070CZ, Lot Number 4034826;  101/800/070CZ, Lot Number 4037975;  101/800/070CZ, Lot Number 4133612;  101/800/070CZ, Lot Number 4152440;  101/800/070CZ, Lot Number 4156971;  101/800/070CZ, Lot Number 4217804;  101/800/070CZ, Lot Number 4238237;  101/800/070CZ, Lot Number 4249341;  101/800/070CZ, Lot Number 4305944;  101/800/070CZ, Lot Number 4305947;  101/800/070CZ, Lot Number 4368641;  101/800/075CZ, Lot Number 3895100;  101/800/075CZ, Lot Number 3925748;  101/800/075CZ, Lot Number 3933086;  101/800/075CZ, Lot Number 4025599;  101/800/075CZ, Lot Number 4034825;  101/800/075CZ, Lot Number 4037974;  101/800/075CZ, Lot Number 4073768;  101/800/075CZ, Lot Number 4117927;  101/800/075CZ, Lot Number 4134827;  101/800/075CZ, Lot Number 4152439;  101/800/075CZ, Lot Number 4156970;  101/800/075CZ, Lot Number 4238234;  101/800/075CZ, Lot Number 4249234;  101/800/075CZ, Lot Number 4348898;  101/800/075CZ, Lot Number 4348899;  101/800/075CZ, Lot Number 4365892;  101/800/080CZ, Lot Number 3895103;  101/800/080CZ, Lot Number 3909670;  101/800/080CZ, Lot Number 3933044;  101/800/080CZ, Lot Number 4037971;  101/800/080CZ, Lot Number 4052621;  101/800/080CZ, Lot Number 4138225;  101/800/080CZ, Lot Number 4156969;  101/800/080CZ, Lot Number 4224695;  101/800/080CZ, Lot Number 4230078;  101/800/080CZ, Lot Number 4232686;  101/800/080CZ, Lot Number 4245469;  101/800/080CZ, Lot Number 4247407;  101/800/080CZ, Lot Number 4270931;  101/800/080CZ, Lot Number 4291190;  101/800/080CZ, Lot Number 4305933;  101/800/080CZ, Lot Number 4305934;  101/800/080CZ, Lot Number 4305935;  101/800/080CZ, Lot Number 4305936;  101/800/080CZ, Lot Number 4305938;  101/800/085CZ, Lot Number 3922027;  101/800/085CZ, Lot Number 3951221;  101/800/085CZ, Lot Number 4034824;  101/800/085CZ, Lot Number 4256383;  101/800/085CZ, Lot Number 4348861;  101/800/090CZ, Lot Number 3895099;  101/800/090CZ, Lot Number 3951220;  101/800/090CZ, Lot Number 3968406;  101/800/090CZ, Lot Number 4039797;  101/800/090CZ, Lot Number 4197025;  101/800/090CZ, Lot Number 4217803;  101/800/090CZ, Lot Number 4238236;  101/800/090CZ, Lot Number 4261648;  101/800/090CZ, Lot Number 4273231;  101/800/090CZ, Lot Number 4306047;  101/800/090CZ, Lot Number 4310439;  101/800/090CZ, Lot Number 4376612;  101/800/090CZ, Lot Number 4387369;  101/800/100CZ, Lot Number 3895110;  101/800/100CZ, Lot Number 3951219;  101/800/100CZ, Lot Number 4000129;  101/800/100CZ, Lot Number 4230076;  101/800/100CZ, Lot Number 4306058;  101/800/100CZ, Lot Number 4372161;  101/800/100CZ, Lot Number 4386600;  101/800/100CZ, Lot Number 4390744;  101/800/100CZ, Lot Number 4413606;  101/802/060CZ, Lot Number 3906886;  101/802/060CZ, Lot Number 3925839;  101/802/060CZ, Lot Number 4028452;  101/802/060CZ, Lot Number 4382046;  101/802/070CZ, Lot Number 3895109;  101/802/070CZ, Lot Number 3925740;  101/802/070CZ, Lot Number 3972531;  101/802/075CZ, Lot Number 3895104;  101/802/075CZ, Lot Number 3951183;  101/802/075CZ, Lot Number 3968265;  101/802/075CZ, Lot Number 4388729;  101/802/080CZ, Lot Number 3895105;  101/802/080CZ, Lot Number 3951185;  101/802/080CZ, Lot Number 4268672;  101/802/080CZ, Lot Number 4310441;  101/802/080CZ, Lot Number 4423828;  101/802/080CZ, Lot Number 4436040;  101/802/080CZ, Lot Number 4444762;  101/802/080CZ, Lot Number 4456953;  101/802/085CZ, Lot Number 3922029;  101/802/085CZ, Lot Number 3925759;  101/802/085CZ, Lot Number 4028454;  101/802/090CZ, Lot Number 3895106;  101/802/090CZ, Lot Number 3925752;  101/802/090CZ, Lot Number 3954847;  101/802/100CZ, Lot Number 3910328;  101/802/100CZ, Lot Number 3951214;  101/802/100CZ, Lot Number 3968282;  101/810/060CZ, Lot Number 3887495;  101/810/060CZ, Lot Number 3933190;  101/810/060CZ, Lot Number 3948313;  101/810/060CZ, Lot Number 3958315;  101/810/060CZ, Lot Number 4106722;  101/810/060CZ, Lot Number 4268673;  101/810/070CZ, Lot Number 3887478;  101/810/070CZ, Lot Number 4106813;  101/810/070CZ, Lot Number 4243097;  101/810/070CZ, Lot Number 4254571;  101/810/070CZ, Lot Number 4285856;  101/810/075, Lot Number 4271670;  101/810/075CZ, Lot Number 3887504;  101/810/075CZ, Lot Number 3925795;  101/810/075CZ, Lot Number 4010055;  101/810/075CZ, Lot Number 4073763;  101/810/075CZ, Lot Number 4177908;  101/810/075CZ, Lot Number 4222083;  101/810/075CZ, Lot Number 4249233;  101/810/075CZ, Lot Number 4281153;  101/810/075CZ, Lot Number 4381994;  101/810/075CZ, Lot Number 4412129;  101/810/080, Lot Number 3900816;  101/810/080CZ, Lot Number 3887481;  101/810/080CZ, Lot Number 4173265;  101/810/080CZ, Lot Number 4207825;  101/810/080CZ, Lot Number 4217114;  101/810/080CZ, Lot Number 4230143;  101/810/080CZ, Lot Number 4285773;  101/810/080CZ, Lot Number 4306016;  101/810/080CZ, Lot Number 4312272;  101/810/080CZ, Lot Number 4381980;  101/810/080CZ, Lot Number 4387365;  101/810/080CZ, Lot Number 4403461;  101/810/080CZ, Lot Number 4415817;  101/810/080CZ, Lot Number 4423832;  101/810/085CZ, Lot Number 3922028;  101/810/085CZ, Lot Number 3951211;  101/810/085CZ, Lot Number 3989280;  101/810/085CZ, Lot Number 4067915;  101/810/085CZ, Lot Number 4098973;  101/810/085CZ, Lot Number 4152435;  101/810/085CZ, Lot Number 4178022;  101/810/085CZ, Lot Number 4281079;  101/810/085CZ, Lot Number 4306011;  101/810/090CZ, Lot Number 3887482;  101/810/090CZ, Lot Number 3993623;  101/810/090CZ, Lot Number 4106736;  101/810/090CZ, Lot Number 4173266;  101/810/090CZ, Lot Number 4243117;  101/810/090CZ, Lot Number 4306027;  101/810/090CZ, Lot Number 4327669;  101/810/090CZ, Lot Number 4403367;  101/810/090CZ, Lot Number 4426600;  101/810/090CZ, Lot Number 4458561;  101/810/100CZ, Lot Number 3887505;  101/810/100CZ, Lot Number 3909242;  101/810/100CZ, Lot Number 4058669;  101/810/100CZ, Lot Number 4175497;  101/810/100CZ, Lot Number 4217875;  101/810/100CZ, Lot Number 4249333;  101/810/100CZ, Lot Number 4291208;  101/810/100CZ, Lot Number 4310443;  101/810/100CZ, Lot Number 4312263;  101/810/100CZ, Lot Number 4387368;  101/810/100CZ, Lot Number 4397557;  101/812/060CZ, Lot Number 3887479;  101/812/060CZ, Lot Number 3925779;  101/812/060CZ, Lot Number 3959080;  101/812/060CZ, Lot Number 3976752;  101/812/060CZ, Lot Number 4106752;  101/812/060CZ, Lot Number 4294444;  101/812/070CZ, Lot Number 3887499;  101/812/070CZ, Lot Number 3925781;  101/812/070CZ, Lot Number 3948188;  101/812/070CZ, Lot Number 3968279;  101/812/070CZ, Lot Number 4106754;  101/812/070CZ, Lot Number 4242910;  101/812/075CZ, Lot Number 3887552;  101/812/075CZ, Lot Number 3968280;  101/812/075CZ, Lot Number 4217831;  101/812/075CZ, Lot Number 4268677;  101/812/075CZ, Lot Number 4381979;  101/812/075CZ, Lot Number 4413594;  101/812/080CZ, Lot Number 3887488;  101/812/080CZ, Lot Number 3948295;  101/812/080CZ, Lot Number 3989255;  101/812/080CZ, Lot Number 4073770;  101/812/080CZ, Lot Number 4106756;  101/812/080CZ, Lot Number 4227246;  101/812/080CZ, Lot Number 4234757;  101/812/080CZ, Lot Number 4385065;  101/812/085CZ, Lot Number 3922030;  101/812/085CZ, Lot Number 3925793;  101/812/085CZ, Lot Number 4028504;  101/812/085CZ, Lot Number 4191164;  101/812/085CZ, Lot Number 4222085;  101/812/085CZ, Lot Number 4261649;  101/812/085CZ, Lot Number 4382043;  101/812/090CZ, Lot Number 3887489;  101/812/090CZ, Lot Number 3972311;  101/812/090CZ, Lot Number 4075795;  101/812/090CZ, Lot Number 4106757;  101/812/090CZ, Lot Number 4170983;  101/812/090CZ, Lot Number 4217120;  101/812/090CZ, Lot Number 4243118;  101/812/100CZ, Lot Number 3887507;  101/812/100CZ, Lot Number 3948187;  101/812/100CZ, Lot Number 4064797;  101/812/100CZ, Lot Number 4245460;  101/812/100CZ, Lot Number 4259283;  101/812/100CZ, Lot Number 4381995;  101/812/100CZ, Lot Number 4388732;  101/812/100CZ, Lot Number 4413618;  101/812/100CZ, Lot Number 4423838;  101/812/100CZ, Lot Number 4443290;  101/815/060, Lot Number 3933722;  101/815/060, Lot Number 3940999;  101/815/060, Lot Number 3949223;  101/815/060, Lot Number 4014730;  101/815/060, Lot Number 4021067;  101/815/060, Lot Number 4035539;  101/815/060, Lot Number 4091934;  101/815/060, Lot Number 4118283;  101/815/060, Lot Number 4121883;  101/815/060, Lot Number 4159150;  101/815/060, Lot Number 4164109;  101/815/060, Lot Number 4166710;  101/815/060, Lot Number 4174793;  101/815/060, Lot Number 4177293;  101/815/060, Lot Number 4177295;  101/815/060, Lot Number 4187097;  101/815/060, Lot Number 4269270;  101/815/060, Lot Number 4369411;  101/815/060, Lot Number 4369412;  101/815/060, Lot Number 4380967;  101/815/070, Lot Number 3905154;  101/815/070, Lot Number 3949269;  101/815/070, Lot Number 3965244;  101/815/070, Lot Number 4032511;  101/815/070, Lot Number 4039241;  101/815/070, Lot Number 4091935;  101/815/070, Lot Number 4115649;  101/815/070, Lot Number 4121851;  101/815/070, Lot Number 4131921;  101/815/070, Lot Number 4187074;  101/815/070, Lot Number 4187085;  101/815/070, Lot Number 4196637;  101/815/070, Lot Number 4214909;  101/815/070, Lot Number 4219471;  101/815/070, Lot Number 4220399;  101/815/070, Lot Number 4223153;  101/815/070, Lot Number 4260338;  101/815/070, Lot Number 4277368;  101/815/070, Lot Number 4292624;  101/815/070, Lot Number 4294949;  101/815/070, Lot Number 4306727;  101/815/070, Lot Number 4306851;  101/815/070, Lot Number 4306852;  101/815/070, Lot Number 4332676;  101/815/070, Lot Number 4332678;  101/815/070, Lot Number 4332684;  101/815/070, Lot Number 4336640;  101/815/070, Lot Number 4369413;  101/815/075, Lot Number 3956297;  101/815/075, Lot Number 4071378;  101/815/075, Lot Number 4126686;  101/815/075, Lot Number 4174782;  101/815/075, Lot Number 4294945;  101/815/075, Lot Number 4332682;  101/815/075, Lot Number 4362485;  101/815/075, Lot Number 4414625;  101/815/075, Lot Number 4428012;  101/815/080, Lot Number 3905015;  101/815/080, Lot Number 3940109;  101/815/080, Lot Number 3942887;  101/815/080, Lot Number 3965245;  101/815/080, Lot Number 4021055;  101/815/080, Lot Number 4029161;  101/815/080, Lot Number 4058347;  101/815/080, Lot Number 4100474;  101/815/080, Lot Number 4118284;  101/815/080, Lot Number 4169838;  101/815/080, Lot Number 4187081;  101/815/080, Lot Number 4190342;  101/815/080, Lot Number 4192320;  101/815/080, Lot Number 4202303;  101/815/080, Lot Number 4204265;  101/815/080, Lot Number 4204266;  101/815/080, Lot Number 4206466;  101/815/080, Lot Number 4209172;  101/815/080, Lot Number 4274832;  101/815/080, Lot Number 4294948;  101/815/080, Lot Number 4336646;  101/815/080, Lot Number 4336649;  101/815/080, Lot Number 4336668;  101/815/085, Lot Number 3956296;  101/815/085, Lot Number 4071392;  101/815/085, Lot Number 4090264;  101/815/085, Lot Number 4209173;  101/815/085, Lot Number 4332683;  101/815/085, Lot Number 4369414;  101/815/090, Lot Number 3933809;  101/815/090, Lot Number 3949146;  101/815/090, Lot Number 4011017;  101/815/090, Lot Number 4021088;  101/815/090, Lot Number 4026491;  101/815/090, Lot Number 4076707;  101/815/090, Lot Number 4159151;  101/815/090, Lot Number 4169840;  101/815/090, Lot Number 4169841;  101/815/090, Lot Number 4178241;  101/815/090, Lot Number 4185327;  101/815/090, Lot Number 4200170;  101/815/090, Lot Number 4200171;  101/815/090, Lot Number 4204267;  101/815/090, Lot Number 4212316;  101/815/090, Lot Number 4216557;  101/815/090, Lot Number 4260339;  101/815/090, Lot Number 4279525;  101/815/090, Lot Number 4294947;  101/815/090, Lot Number 4334212;  101/815/090, Lot Number 4336647;  101/815/090, Lot Number 4336650;  101/815/100, Lot Number 3933697;  101/815/100, Lot Number 4021081;  101/815/100, Lot Number 4029154;  101/815/100, Lot Number 4112822;  101/815/100, Lot Number 4148895;  101/815/100, Lot Number 4161638;  101/815/100, Lot Number 4169842;  101/815/100, Lot Number 4187096;  101/815/100, Lot Number 4192321;  101/815/100, Lot Number 4206174;  101/815/100, Lot Number 4284378;  101/817/060, Lot Number 3905152;  101/817/060, Lot Number 4106973;  101/817/060, Lot Number 4174794;  101/817/070, Lot Number 3956189;  101/817/070, Lot Number 3986585;  101/817/070, Lot Number 4107000;  101/817/070, Lot Number 4118288;  101/817/070, Lot Number 4130527;  101/817/070, Lot Number 4187078;  101/817/070, Lot Number 4208001;  101/817/080, Lot Number 3933831;  101/817/080, Lot Number 3962715;  101/817/080, Lot Number 4062550;  101/817/080, Lot Number 4068195;  101/817/080, Lot Number 4230801;  101/817/080, Lot Number 4294937;  101/817/090, Lot Number 3941008;  101/817/090, Lot Number 4071380;  101/817/090, Lot Number 4076692;  101/817/090, Lot Number 4106651;  101/817/100, Lot Number 3933799;  101/817/100, Lot Number 4187080;  101/860/060CZ, Lot Number 3895092;  101/860/060CZ, Lot Number 3951193;  101/860/060CZ, Lot Number 4010035;  101/860/060CZ, Lot Number 4058593;  101/860/060CZ, Lot Number 4117932;  101/860/060CZ, Lot Number 4134876;  101/860/060CZ, Lot Number 4156952;  101/860/060CZ, Lot Number 4177861;  101/860/060CZ, Lot Number 4242923;  101/860/060CZ, Lot Number 4376593;  101/860/070CZ, Lot Number 3887509;  101/860/070CZ, Lot Number 3895108;  101/860/070CZ, Lot Number 3951303;  101/860/070CZ, Lot Number 3959094;  101/860/070CZ, Lot Number 3993578;  101/860/070CZ, Lot Number 4010067;  101/860/070CZ, Lot Number 4017181;  101/860/070CZ, Lot Number 4022712;  101/860/070CZ, Lot Number 4025593;  101/860/070CZ, Lot Number 4037923;  101/860/070CZ, Lot Number 4039786;  101/860/070CZ, Lot Number 4052498;  101/860/070CZ, Lot Number 4053320;  101/860/070CZ, Lot Number 4058579;  101/860/070CZ, Lot Number 4061184;  101/860/070CZ, Lot Number 4062929;  101/860/070CZ, Lot Number 4067465;  101/860/070CZ, Lot Number 4067814;  101/860/070CZ, Lot Number 4074986;  101/860/070CZ, Lot Number 4138104;  101/860/070CZ, Lot Number 4163119;  101/860/070CZ, Lot Number 4165742;  101/860/070CZ, Lot Number 4170834;  101/860/070CZ, Lot Number 4183961;  101/860/070CZ, Lot Number 4186645;  101/860/070CZ, Lot Number 4186963;  101/860/070CZ, Lot Number 4198020;  101/860/070CZ, Lot Number 4202488;  101/860/070CZ, Lot Number 4205530;  101/860/070CZ, Lot Number 4221990;  101/860/070CZ, Lot Number 4232682;  101/860/070CZ, Lot Number 4234708;  101/860/070CZ, Lot Number 4234709;  101/860/070CZ, Lot Number 4249306;  101/860/070CZ, Lot Number 4252463;  101/860/070CZ, Lot Number 4252464;  101/860/070CZ, Lot Number 4285771;  101/860/070CZ, Lot Number 4294329;  101/860/070CZ, Lot Number 4303383;  101/860/070CZ, Lot Number 4306006;  101/860/070CZ, Lot Number 4306007;  101/860/070CZ, Lot Number 4306008;  101/860/070CZ, Lot Number 4368707;  101/860/070CZ, Lot Number 4370061;  101/860/075CZ, Lot Number 3895094;  101/860/075CZ, Lot Number 3909675;  101/860/075CZ, Lot Number 3951196;  101/860/075CZ, Lot Number 3951197;  101/860/075CZ, Lot Number 3954753;  101/860/075CZ, Lot Number 4002904;  101/860/075CZ, Lot Number 4005269;  101/860/075CZ, Lot Number 4010074;  101/860/075CZ, Lot Number 4017180;  101/860/075CZ, Lot Number 4020216;  101/860/075CZ, Lot Number 4022713;  101/860/075CZ, Lot Number 4034797;  101/860/075CZ, Lot Number 4037922;  101/860/075CZ, Lot Number 4052614;  101/860/075CZ, Lot Number 4054784;  101/860/075CZ, Lot Number 4054785;  101/860/075CZ, Lot Number 4054787;  101/860/075CZ, Lot Number 4062434;  101/860/075CZ, Lot Number 4062931;  101/860/075CZ, Lot Number 4065368;  101/860/075CZ, Lot Number 4065369;  101/860/075CZ, Lot Number 4067466;  101/860/075CZ, Lot Number 4117933;  101/860/075CZ, Lot Number 4122876;  101/860/075CZ, Lot Number 4127325;  101/860/075CZ, Lot Number 4129462;  101/860/075CZ, Lot Number 4133614;  101/860/075CZ, Lot Number 4134878;  101/860/075CZ, Lot Number 4138103;  101/860/075CZ, Lot Number 4139223;  101/860/075CZ, Lot Number 4139224;  101/860/075CZ, Lot Number 4165615;  101/860/075CZ, Lot Number 4170859;  101/860/075CZ, Lot Number 4183962;  101/860/075CZ, Lot Number 4183963;  101/860/075CZ, Lot Number 4186583;  101/860/075CZ, Lot Number 4186965;  101/860/075CZ, Lot Number 4189388;  101/860/075CZ, Lot Number 4197067;  101/860/075CZ, Lot Number 4199269;  101/860/075CZ, Lot Number 4199270;  101/860/075CZ, Lot Number 4212066;  101/860/075CZ, Lot Number 4214633;  101/860/075CZ, Lot Number 4214634;  101/860/075CZ, Lot Number 4217813;  101/860/075CZ, Lot Number 4221051;  101/860/075CZ, Lot Number 4224578;  101/860/075CZ, Lot Number 4225227;  101/860/075CZ, Lot Number 4242918;  101/860/075CZ, Lot Number 4243105;  101/860/075CZ, Lot Number 4245286;  101/860/075CZ, Lot Number 4249223;  101/860/075CZ, Lot Number 4252465;  101/860/075CZ, Lot Number 4254572;  101/860/075CZ, Lot Number 4259236;  101/860/075CZ, Lot Number 4270939;  101/860/075CZ, Lot Number 4281157;  101/860/075CZ, Lot Number 4285842;  101/860/075CZ, Lot Number 4285843;  101/860/075CZ, Lot Number 4285844;  101/860/075CZ, Lot Number 4294330;  101/860/075CZ, Lot Number 4306004; 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 101/860/080CZ, Lot Number 4031414;  101/860/080CZ, Lot Number 4031415;  101/860/080CZ, Lot Number 4031416;  101/860/080CZ, Lot Number 4034842;  101/860/080CZ, Lot Number 4037140;  101/860/080CZ, Lot Number 4037141;  101/860/080CZ, Lot Number 4037986;  101/860/080CZ, Lot Number 4041420;  101/860/080CZ, Lot Number 4054804;  101/860/080CZ, Lot Number 4054805;  101/860/080CZ, Lot Number 4057098;  101/860/080CZ, Lot Number 4058607;  101/860/080CZ, Lot Number 4058608;  101/860/080CZ, Lot Number 4061058;  101/860/080CZ, Lot Number 4061061;  101/860/080CZ, Lot Number 4061062;  101/860/080CZ, Lot Number 4067791;  101/860/080CZ, Lot Number 4071181;  101/860/080CZ, Lot Number 4071182;  101/860/080CZ, Lot Number 4079446;  101/860/080CZ, Lot Number 4079447;  101/860/080CZ, Lot Number 4079448;  101/860/080CZ, Lot Number 4133622;  101/860/080CZ, Lot Number 4134843;  101/860/080CZ, Lot Number 4134844;  101/860/080CZ, Lot Number 4134845;  101/860/080CZ, Lot Number 4134846;  101/860/080CZ, Lot Number 4136573;  101/860/080CZ, Lot Number 4136574;  101/860/080CZ, Lot Number 4136575;  101/860/080CZ, Lot Number 4165613;  101/860/080CZ, Lot Number 4165614;  101/860/080CZ, Lot Number 4170920;  101/860/080CZ, Lot Number 4178020;  101/860/080CZ, Lot Number 4179046;  101/860/080CZ, Lot Number 4183972;  101/860/080CZ, Lot Number 4186574;  101/860/080CZ, Lot Number 4186575;  101/860/080CZ, Lot Number 4189343;  101/860/080CZ, Lot Number 4191167;  101/860/080CZ, Lot Number 4191168;  101/860/080CZ, Lot Number 4195032;  101/860/080CZ, Lot Number 4202463;  101/860/080CZ, Lot Number 4205543;  101/860/080CZ, Lot Number 4207746;  101/860/080CZ, Lot Number 4211996;  101/860/080CZ, Lot Number 4211997;  101/860/080CZ, Lot Number 4211998;  101/860/080CZ, Lot Number 4214635;  101/860/080CZ, Lot Number 4217853;  101/860/080CZ, Lot Number 4219600;  101/860/080CZ, Lot Number 4221985;  101/860/080CZ, Lot Number 4231321;  101/860/080CZ, Lot Number 4231322;  101/860/080CZ, Lot Number 4232674;  101/860/080CZ, Lot Number 4234707;  101/860/080CZ, Lot Number 4242937;  101/860/080CZ, Lot Number 4249310;  101/860/080CZ, Lot Number 4252471;  101/860/080CZ, Lot Number 4252472;  101/860/080CZ, Lot Number 4254577;  101/860/080CZ, Lot Number 4254578;  101/860/080CZ, Lot Number 4259268;  101/860/080CZ, Lot Number 4259269;  101/860/080CZ, Lot Number 4281080;  101/860/080CZ, Lot Number 4281081;  101/860/080CZ, Lot Number 4283735;  101/860/080CZ, Lot Number 4285774;  101/860/080CZ, Lot Number 4285775;  101/860/080CZ, Lot Number 4305958;  101/860/080CZ, Lot Number 4305959;  101/860/080CZ, Lot Number 4312278;  101/860/080CZ, Lot Number 4312279;  101/860/080CZ, Lot Number 4312280;  101/860/080CZ, Lot Number 4319745;  101/860/080CZ, Lot Number 4319746;  101/860/080CZ, Lot Number 4357891;  101/860/080CZ, Lot Number 4365949;  101/860/080CZ, Lot Number 4376685;  101/860/080CZ, Lot Number 4376686;  101/860/080CZ, Lot Number 4376687;  101/860/080CZ, Lot Number 4384987;  101/860/080CZ, Lot Number 4384988;  101/860/080CZ, Lot Number 4386575; 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 101/860/090CZ, Lot Number 4306064;  101/860/090CZ, Lot Number 4310533;  101/860/090CZ, Lot Number 4382009;  101/860/090CZ, Lot Number 4385029;  101/860/100CZ, Lot Number 3895093;  101/860/100CZ, Lot Number 3925786;  101/860/100CZ, Lot Number 3951305;  101/860/100CZ, Lot Number 3968281;  101/860/100CZ, Lot Number 4010004;  101/860/100CZ, Lot Number 4025595;  101/860/100CZ, Lot Number 4054789;  101/860/100CZ, Lot Number 4199355;  101/860/100CZ, Lot Number 4217881;  101/860/100CZ, Lot Number 4285765;  101/860/100CZ, Lot Number 4412135;  101/870/060CZ, Lot Number 3887510;  101/870/060CZ, Lot Number 3925734;  101/870/060CZ, Lot Number 3951306;  101/870/060CZ, Lot Number 4031337;  101/870/060CZ, Lot Number 4106745;  101/870/060CZ, Lot Number 4217882;  101/870/070CZ, Lot Number 3889311;  101/870/070CZ, Lot Number 3951204;  101/870/070CZ, Lot Number 3968404;  101/870/070CZ, Lot Number 4017237;  101/870/070CZ, Lot Number 4022711;  101/870/070CZ, Lot Number 4034792;  101/870/070CZ, Lot Number 4058662;  101/870/070CZ, Lot Number 4073762;  101/870/070CZ, Lot Number 4134828;  101/870/070CZ, Lot Number 4138214;  101/870/070CZ, Lot Number 4156953;  101/870/070CZ, Lot Number 4165744;  101/870/070CZ, Lot Number 4178001;  101/870/070CZ, Lot Number 4217826;  101/870/070CZ, Lot Number 4249291;  101/870/070CZ, Lot Number 4256336;  101/870/070CZ, Lot Number 4283719;  101/870/070CZ, Lot Number 4291171;  101/870/075CZ, Lot Number 3906881;  101/870/075CZ, Lot Number 3951207;  101/870/075CZ, Lot Number 3968405;  101/870/075CZ, Lot Number 4054813;  101/870/075CZ, Lot Number 4058606;  101/870/075CZ, Lot Number 4061022;  101/870/075CZ, Lot Number 4134829;  101/870/075CZ, Lot Number 4138176;  101/870/075CZ, Lot Number 4183954;  101/870/075CZ, Lot Number 4212004;  101/870/075CZ, Lot Number 4238185;  101/870/075CZ, Lot Number 4249236;  101/870/075CZ, Lot Number 4270941;  101/870/075CZ, Lot Number 4276631;  101/870/075CZ, Lot Number 4382010;  101/870/080CZ, Lot Number 3887515;  101/870/080CZ, Lot Number 3951288;  101/870/080CZ, Lot Number 3980351;  101/870/080CZ, Lot Number 3989180;  101/870/080CZ, Lot Number 4017250;  101/870/080CZ, Lot Number 4051928;  101/870/080CZ, Lot Number 4054796;  101/870/080CZ, Lot Number 4070522;  101/870/080CZ, Lot Number 4117931;  101/870/080CZ, Lot Number 4134866;  101/870/080CZ, Lot Number 4138056;  101/870/080CZ, Lot Number 4156930;  101/870/080CZ, Lot Number 4163106;  101/870/080CZ, Lot Number 4208997;  101/870/080CZ, Lot Number 4238168;  101/870/080CZ, Lot Number 4254564;  101/870/080CZ, Lot Number 4303380;  101/870/080CZ, Lot Number 4310523;  101/870/080CZ, Lot Number 4312285;  101/870/080CZ, Lot Number 4317581;  101/870/080CZ, Lot Number 4319800;  101/870/080CZ, Lot Number 4368642;  101/870/080CZ, Lot Number 4388736;  101/870/080CZ, Lot Number 4390747;  101/870/085CZ, Lot Number 3887484;  101/870/085CZ, Lot Number 3925788;  101/870/085CZ, Lot Number 4002986;  101/870/085CZ, Lot Number 4054842;  101/870/085CZ, Lot Number 4085217;  101/870/085CZ, Lot Number 4110784;  101/870/085CZ, Lot Number 4121517;  101/870/085CZ, Lot Number 4156983;  101/870/085CZ, Lot Number 4183981;  101/870/085CZ, Lot Number 4212070;  101/870/085CZ, Lot Number 4245285;  101/870/085CZ, Lot Number 4249238;  101/870/085CZ, Lot Number 4376585;  101/870/090CZ, Lot Number 3892136;  101/870/090CZ, Lot Number 3907683;  101/870/090CZ, Lot Number 3951191;  101/870/090CZ, Lot Number 3962340;  101/870/090CZ, Lot Number 4000188;  101/870/090CZ, Lot Number 4061185;  101/870/090CZ, Lot Number 4075797;  101/870/090CZ, Lot Number 4106832;  101/870/090CZ, Lot Number 4129451;  101/870/090CZ, Lot Number 4138105;  101/870/090CZ, Lot Number 4155508;  101/870/090CZ, Lot Number 4178002;  101/870/090CZ, Lot Number 4183974;  101/870/090CZ, Lot Number 4242948;  101/870/090CZ, Lot Number 4249307;  101/870/090CZ, Lot Number 4249334;  101/870/090CZ, Lot Number 4276656;  101/870/090CZ, Lot Number 4285763;  101/870/090CZ, Lot Number 4285764;  101/870/090CZ, Lot Number 4303381;  101/870/090CZ, Lot Number 4387367;  101/870/100CZ, Lot Number 3887465;  101/870/100CZ, Lot Number 3925771;  101/870/100CZ, Lot Number 3996000;  101/870/100CZ, Lot Number 4075798;  101/870/100CZ, Lot Number 4087868;  101/870/100CZ, Lot Number 4106718;  101/870/100CZ, Lot Number 4209008;  101/870/100CZ, Lot Number 4217806;  101/870/100CZ, Lot Number 4245461;  101/870/100CZ, Lot Number 4256343;  101/870/100CZ, Lot Number 4306010;  101/875/060, Lot Number 3973580;  101/875/060, Lot Number 3994206;  101/875/060, Lot Number 4077390;  101/875/060, Lot Number 4077409;  101/875/060, Lot Number 4097405;  101/875/060, Lot Number 4106652;  101/875/060, Lot Number 4121852;  101/875/060, Lot Number 4174792;  101/875/060, Lot Number 4185328;  101/875/060, Lot Number 4228918;  101/875/060, Lot Number 4294942;  101/875/060, Lot Number 4306861;  101/875/070, Lot Number 3965241;  101/875/070, Lot Number 3997476;  101/875/070, Lot Number 4040743;  101/875/070, Lot Number 4040744;  101/875/070, Lot Number 4040748;  101/875/070, Lot Number 4083147;  101/875/070, Lot Number 4090267;  101/875/070, Lot Number 4106653;  101/875/070, Lot Number 4106657;  101/875/070, Lot Number 4130528;  101/875/070, Lot Number 4219470;  101/875/070, Lot Number 4244044;  101/875/070, Lot Number 4244045;  101/875/075, Lot Number 3956207;  101/875/075, Lot Number 3965238;  101/875/075, Lot Number 4106984;  101/875/075, Lot Number 4230803;  101/875/075, Lot Number 4294936;  101/875/075, Lot Number 4318743;  101/875/075, Lot Number 4380983;  101/875/080, Lot Number 3905060;  101/875/080, Lot Number 4038638;  101/875/080, Lot Number 4071393;  101/875/080, Lot Number 4083162;  101/875/080, Lot Number 4088887;  101/875/080, Lot Number 4091522;  101/875/080, Lot Number 4106655;  101/875/080, Lot Number 4124771;  101/875/080, Lot Number 4187079;  101/875/080, Lot Number 4187084;  101/875/080, Lot Number 4202304;  101/875/080, Lot Number 4220404;  101/875/080, Lot Number 4279527;  101/875/080, Lot Number 4294941;  101/875/080, Lot Number 4375952;  101/875/085, Lot Number 3956339;  101/875/085, Lot Number 4106981;  101/875/085, Lot Number 4119879;  101/875/085, Lot Number 4187077;  101/875/085, Lot Number 4202297;  101/875/085, Lot Number 4216554;  101/875/090, Lot Number 4034431;  101/875/090, Lot Number 4067217;  101/875/090, Lot Number 4068186;  101/875/090, Lot Number 4106650;  101/875/090, Lot Number 4106999;  101/875/090, Lot Number 4115631;  101/875/090, Lot Number 4118290;  101/875/090, Lot Number 4187086;  101/875/090, Lot Number 4206467;  101/875/090, Lot Number 4216550;  101/875/090, Lot Number 4220407;  101/875/100, Lot Number 3905062. 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-3086-2024&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-3086-2024&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-3086-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3086-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3086-2024&lang=eng",
        "value": "Class I",
        "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-3086-2024&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-3086-2024/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",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-3086-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-3086-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Smiths Medical ASD Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-06-07",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
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            "Value": "101/800/060CZ, Lot Number 3895097;  101/800/060CZ, Lot Number 3925835;  101/800/060CZ, Lot Number 4025600;  101/800/060CZ, Lot Number 4106716;  101/800/060CZ, Lot Number 4230149;  101/800/060CZ, Lot Number 4252500;  101/800/060CZ, Lot Number 4382002;  101/800/070CZ, Lot Number 3895101;  101/800/070CZ, Lot Number 3925960;  101/800/070CZ, Lot Number 3933088;  101/800/070CZ, Lot Number 4010050;  101/800/070CZ, Lot Number 4022790;  101/800/070CZ, Lot Number 4034826;  101/800/070CZ, Lot Number 4037975;  101/800/070CZ, Lot Number 4133612;  101/800/070CZ, Lot Number 4152440;  101/800/070CZ, Lot Number 4156971;  101/800/070CZ, Lot Number 4217804;  101/800/070CZ, Lot Number 4238237;  101/800/070CZ, Lot Number 4249341;  101/800/070CZ, Lot Number 4305944;  101/800/070CZ, Lot Number 4305947;  101/800/070CZ, Lot Number 4368641;  101/800/075CZ, Lot Number 3895100;  101/800/075CZ, Lot Number 3925748;  101/800/075CZ, Lot Number 3933086;  101/800/075CZ, Lot Number 4025599;  101/800/075CZ, Lot Number 4034825; 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 101/810/080CZ, Lot Number 4230143;  101/810/080CZ, Lot Number 4285773;  101/810/080CZ, Lot Number 4306016;  101/810/080CZ, Lot Number 4312272;  101/810/080CZ, Lot Number 4381980;  101/810/080CZ, Lot Number 4387365;  101/810/080CZ, Lot Number 4403461;  101/810/080CZ, Lot Number 4415817;  101/810/080CZ, Lot Number 4423832;  101/810/085CZ, Lot Number 3922028;  101/810/085CZ, Lot Number 3951211;  101/810/085CZ, Lot Number 3989280;  101/810/085CZ, Lot Number 4067915;  101/810/085CZ, Lot Number 4098973;  101/810/085CZ, Lot Number 4152435;  101/810/085CZ, Lot Number 4178022;  101/810/085CZ, Lot Number 4281079;  101/810/085CZ, Lot Number 4306011;  101/810/090CZ, Lot Number 3887482;  101/810/090CZ, Lot Number 3993623;  101/810/090CZ, Lot Number 4106736;  101/810/090CZ, Lot Number 4173266;  101/810/090CZ, Lot Number 4243117;  101/810/090CZ, Lot Number 4306027;  101/810/090CZ, Lot Number 4327669;  101/810/090CZ, Lot Number 4403367;  101/810/090CZ, Lot Number 4426600;  101/810/090CZ, Lot Number 4458561;  101/810/100CZ, Lot Number 3887505;  101/810/100CZ, Lot Number 3909242;  101/810/100CZ, Lot Number 4058669;  101/810/100CZ, Lot Number 4175497;  101/810/100CZ, Lot Number 4217875;  101/810/100CZ, Lot Number 4249333;  101/810/100CZ, Lot Number 4291208;  101/810/100CZ, Lot Number 4310443;  101/810/100CZ, Lot Number 4312263;  101/810/100CZ, Lot Number 4387368;  101/810/100CZ, Lot Number 4397557;  101/812/060CZ, Lot Number 3887479;  101/812/060CZ, Lot Number 3925779;  101/812/060CZ, Lot Number 3959080;  101/812/060CZ, Lot Number 3976752;  101/812/060CZ, Lot Number 4106752;  101/812/060CZ, Lot Number 4294444;  101/812/070CZ, Lot Number 3887499;  101/812/070CZ, Lot Number 3925781;  101/812/070CZ, Lot Number 3948188;  101/812/070CZ, Lot Number 3968279;  101/812/070CZ, Lot Number 4106754;  101/812/070CZ, Lot Number 4242910;  101/812/075CZ, Lot Number 3887552;  101/812/075CZ, Lot Number 3968280;  101/812/075CZ, Lot Number 4217831;  101/812/075CZ, Lot Number 4268677;  101/812/075CZ, Lot Number 4381979; 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 101/812/100CZ, Lot Number 4381995;  101/812/100CZ, Lot Number 4388732;  101/812/100CZ, Lot Number 4413618;  101/812/100CZ, Lot Number 4423838;  101/812/100CZ, Lot Number 4443290;  101/815/060, Lot Number 3933722;  101/815/060, Lot Number 3940999;  101/815/060, Lot Number 3949223;  101/815/060, Lot Number 4014730;  101/815/060, Lot Number 4021067;  101/815/060, Lot Number 4035539;  101/815/060, Lot Number 4091934;  101/815/060, Lot Number 4118283;  101/815/060, Lot Number 4121883;  101/815/060, Lot Number 4159150;  101/815/060, Lot Number 4164109;  101/815/060, Lot Number 4166710;  101/815/060, Lot Number 4174793;  101/815/060, Lot Number 4177293;  101/815/060, Lot Number 4177295;  101/815/060, Lot Number 4187097;  101/815/060, Lot Number 4269270;  101/815/060, Lot Number 4369411;  101/815/060, Lot Number 4369412;  101/815/060, Lot Number 4380967;  101/815/070, Lot Number 3905154;  101/815/070, Lot Number 3949269;  101/815/070, Lot Number 3965244;  101/815/070, Lot Number 4032511;  101/815/070, Lot Number 4039241;  101/815/070, Lot Number 4091935;  101/815/070, Lot Number 4115649;  101/815/070, Lot Number 4121851;  101/815/070, Lot Number 4131921;  101/815/070, Lot Number 4187074;  101/815/070, Lot Number 4187085;  101/815/070, Lot Number 4196637;  101/815/070, Lot Number 4214909;  101/815/070, Lot Number 4219471;  101/815/070, Lot Number 4220399;  101/815/070, Lot Number 4223153;  101/815/070, Lot Number 4260338;  101/815/070, Lot Number 4277368;  101/815/070, Lot Number 4292624;  101/815/070, Lot Number 4294949;  101/815/070, Lot Number 4306727;  101/815/070, Lot Number 4306851;  101/815/070, Lot Number 4306852;  101/815/070, Lot Number 4332676;  101/815/070, Lot Number 4332678;  101/815/070, Lot Number 4332684;  101/815/070, Lot Number 4336640;  101/815/070, Lot Number 4369413;  101/815/075, Lot Number 3956297;  101/815/075, Lot Number 4071378;  101/815/075, Lot Number 4126686;  101/815/075, Lot Number 4174782;  101/815/075, Lot Number 4294945;  101/815/075, Lot Number 4332682;  101/815/075, Lot Number 4362485;  101/815/075, Lot Number 4414625;  101/815/075, Lot Number 4428012;  101/815/080, Lot Number 3905015;  101/815/080, Lot Number 3940109;  101/815/080, Lot Number 3942887;  101/815/080, Lot Number 3965245;  101/815/080, Lot Number 4021055;  101/815/080, Lot Number 4029161;  101/815/080, Lot Number 4058347;  101/815/080, Lot Number 4100474;  101/815/080, Lot Number 4118284;  101/815/080, Lot Number 4169838;  101/815/080, Lot Number 4187081;  101/815/080, Lot Number 4190342;  101/815/080, Lot Number 4192320;  101/815/080, Lot Number 4202303;  101/815/080, Lot Number 4204265;  101/815/080, Lot Number 4204266;  101/815/080, Lot Number 4206466;  101/815/080, Lot Number 4209172;  101/815/080, Lot Number 4274832;  101/815/080, Lot Number 4294948;  101/815/080, Lot Number 4336646;  101/815/080, Lot Number 4336649;  101/815/080, Lot Number 4336668;  101/815/085, Lot Number 3956296;  101/815/085, Lot Number 4071392;  101/815/085, Lot Number 4090264;  101/815/085, Lot Number 4209173;  101/815/085, Lot Number 4332683;  101/815/085, Lot Number 4369414;  101/815/090, Lot Number 3933809;  101/815/090, Lot Number 3949146;  101/815/090, Lot Number 4011017;  101/815/090, Lot Number 4021088;  101/815/090, Lot Number 4026491;  101/815/090, Lot Number 4076707;  101/815/090, Lot Number 4159151;  101/815/090, Lot Number 4169840;  101/815/090, Lot Number 4169841;  101/815/090, Lot Number 4178241;  101/815/090, Lot Number 4185327;  101/815/090, Lot Number 4200170;  101/815/090, Lot Number 4200171;  101/815/090, Lot Number 4204267;  101/815/090, Lot Number 4212316;  101/815/090, Lot Number 4216557;  101/815/090, Lot Number 4260339;  101/815/090, Lot Number 4279525;  101/815/090, Lot Number 4294947;  101/815/090, Lot Number 4334212;  101/815/090, Lot Number 4336647;  101/815/090, Lot Number 4336650;  101/815/100, Lot Number 3933697;  101/815/100, Lot Number 4021081;  101/815/100, Lot Number 4029154;  101/815/100, Lot Number 4112822;  101/815/100, Lot Number 4148895;  101/815/100, Lot Number 4161638;  101/815/100, Lot Number 4169842;  101/815/100, Lot Number 4187096;  101/815/100, Lot Number 4192321;  101/815/100, Lot Number 4206174;  101/815/100, Lot Number 4284378;  101/817/060, Lot Number 3905152;  101/817/060, Lot Number 4106973;  101/817/060, Lot Number 4174794;  101/817/070, Lot Number 3956189;  101/817/070, Lot Number 3986585;  101/817/070, Lot Number 4107000;  101/817/070, Lot Number 4118288;  101/817/070, Lot Number 4130527;  101/817/070, Lot Number 4187078;  101/817/070, Lot Number 4208001;  101/817/080, Lot Number 3933831;  101/817/080, Lot Number 3962715;  101/817/080, Lot Number 4062550;  101/817/080, Lot Number 4068195;  101/817/080, Lot Number 4230801;  101/817/080, Lot Number 4294937;  101/817/090, Lot Number 3941008;  101/817/090, Lot Number 4071380;  101/817/090, Lot Number 4076692;  101/817/090, Lot Number 4106651;  101/817/100, Lot Number 3933799;  101/817/100, Lot Number 4187080;  101/860/060CZ, Lot Number 3895092;  101/860/060CZ, Lot Number 3951193;  101/860/060CZ, Lot Number 4010035;  101/860/060CZ, Lot Number 4058593;  101/860/060CZ, Lot Number 4117932;  101/860/060CZ, Lot Number 4134876;  101/860/060CZ, Lot Number 4156952;  101/860/060CZ, Lot Number 4177861;  101/860/060CZ, Lot Number 4242923;  101/860/060CZ, Lot Number 4376593;  101/860/070CZ, Lot Number 3887509;  101/860/070CZ, Lot Number 3895108;  101/860/070CZ, Lot Number 3951303;  101/860/070CZ, Lot Number 3959094;  101/860/070CZ, Lot Number 3993578;  101/860/070CZ, Lot Number 4010067;  101/860/070CZ, Lot Number 4017181;  101/860/070CZ, Lot Number 4022712;  101/860/070CZ, Lot Number 4025593;  101/860/070CZ, Lot Number 4037923;  101/860/070CZ, Lot Number 4039786;  101/860/070CZ, Lot Number 4052498;  101/860/070CZ, Lot Number 4053320;  101/860/070CZ, Lot Number 4058579;  101/860/070CZ, Lot Number 4061184;  101/860/070CZ, Lot Number 4062929;  101/860/070CZ, Lot Number 4067465;  101/860/070CZ, Lot Number 4067814;  101/860/070CZ, Lot Number 4074986;  101/860/070CZ, Lot Number 4138104;  101/860/070CZ, Lot Number 4163119;  101/860/070CZ, Lot Number 4165742;  101/860/070CZ, Lot Number 4170834;  101/860/070CZ, Lot Number 4183961;  101/860/070CZ, Lot Number 4186645;  101/860/070CZ, Lot Number 4186963;  101/860/070CZ, Lot Number 4198020;  101/860/070CZ, Lot Number 4202488;  101/860/070CZ, Lot Number 4205530;  101/860/070CZ, Lot Number 4221990;  101/860/070CZ, Lot Number 4232682;  101/860/070CZ, Lot Number 4234708;  101/860/070CZ, Lot Number 4234709;  101/860/070CZ, Lot Number 4249306;  101/860/070CZ, Lot Number 4252463;  101/860/070CZ, Lot Number 4252464;  101/860/070CZ, Lot Number 4285771;  101/860/070CZ, Lot Number 4294329;  101/860/070CZ, Lot Number 4303383;  101/860/070CZ, Lot Number 4306006;  101/860/070CZ, Lot Number 4306007;  101/860/070CZ, Lot Number 4306008;  101/860/070CZ, Lot Number 4368707;  101/860/070CZ, Lot Number 4370061;  101/860/075CZ, Lot Number 3895094;  101/860/075CZ, Lot Number 3909675;  101/860/075CZ, Lot Number 3951196;  101/860/075CZ, Lot Number 3951197;  101/860/075CZ, Lot Number 3954753;  101/860/075CZ, Lot Number 4002904;  101/860/075CZ, Lot Number 4005269;  101/860/075CZ, Lot Number 4010074;  101/860/075CZ, Lot Number 4017180;  101/860/075CZ, Lot Number 4020216;  101/860/075CZ, Lot Number 4022713;  101/860/075CZ, Lot Number 4034797;  101/860/075CZ, Lot Number 4037922;  101/860/075CZ, Lot Number 4052614;  101/860/075CZ, Lot Number 4054784;  101/860/075CZ, Lot Number 4054785;  101/860/075CZ, Lot Number 4054787;  101/860/075CZ, Lot Number 4062434;  101/860/075CZ, Lot Number 4062931;  101/860/075CZ, Lot Number 4065368;  101/860/075CZ, Lot Number 4065369;  101/860/075CZ, Lot Number 4067466;  101/860/075CZ, Lot Number 4117933;  101/860/075CZ, Lot Number 4122876;  101/860/075CZ, Lot Number 4127325;  101/860/075CZ, Lot Number 4129462;  101/860/075CZ, Lot Number 4133614;  101/860/075CZ, Lot Number 4134878;  101/860/075CZ, Lot Number 4138103;  101/860/075CZ, Lot Number 4139223;  101/860/075CZ, Lot Number 4139224;  101/860/075CZ, Lot Number 4165615;  101/860/075CZ, Lot Number 4170859;  101/860/075CZ, Lot Number 4183962;  101/860/075CZ, Lot Number 4183963;  101/860/075CZ, Lot Number 4186583;  101/860/075CZ, Lot Number 4186965;  101/860/075CZ, Lot Number 4189388;  101/860/075CZ, Lot Number 4197067;  101/860/075CZ, Lot Number 4199269;  101/860/075CZ, Lot Number 4199270;  101/860/075CZ, Lot Number 4212066;  101/860/075CZ, Lot Number 4214633;  101/860/075CZ, Lot Number 4214634;  101/860/075CZ, Lot Number 4217813;  101/860/075CZ, Lot Number 4221051;  101/860/075CZ, Lot Number 4224578;  101/860/075CZ, Lot Number 4225227;  101/860/075CZ, Lot Number 4242918;  101/860/075CZ, Lot Number 4243105;  101/860/075CZ, Lot Number 4245286;  101/860/075CZ, Lot Number 4249223;  101/860/075CZ, Lot Number 4252465;  101/860/075CZ, Lot Number 4254572;  101/860/075CZ, Lot Number 4259236;  101/860/075CZ, Lot Number 4270939;  101/860/075CZ, Lot Number 4281157;  101/860/075CZ, Lot Number 4285842;  101/860/075CZ, Lot Number 4285843;  101/860/075CZ, Lot Number 4285844;  101/860/075CZ, Lot Number 4294330;  101/860/075CZ, Lot Number 4306004; 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 101/860/080CZ, Lot Number 4031414;  101/860/080CZ, Lot Number 4031415;  101/860/080CZ, Lot Number 4031416;  101/860/080CZ, Lot Number 4034842;  101/860/080CZ, Lot Number 4037140;  101/860/080CZ, Lot Number 4037141;  101/860/080CZ, Lot Number 4037986;  101/860/080CZ, Lot Number 4041420;  101/860/080CZ, Lot Number 4054804;  101/860/080CZ, Lot Number 4054805;  101/860/080CZ, Lot Number 4057098;  101/860/080CZ, Lot Number 4058607;  101/860/080CZ, Lot Number 4058608;  101/860/080CZ, Lot Number 4061058;  101/860/080CZ, Lot Number 4061061;  101/860/080CZ, Lot Number 4061062;  101/860/080CZ, Lot Number 4067791;  101/860/080CZ, Lot Number 4071181;  101/860/080CZ, Lot Number 4071182;  101/860/080CZ, Lot Number 4079446;  101/860/080CZ, Lot Number 4079447;  101/860/080CZ, Lot Number 4079448;  101/860/080CZ, Lot Number 4133622;  101/860/080CZ, Lot Number 4134843;  101/860/080CZ, Lot Number 4134844;  101/860/080CZ, Lot Number 4134845;  101/860/080CZ, Lot Number 4134846;  101/860/080CZ, Lot Number 4136573;  101/860/080CZ, Lot Number 4136574;  101/860/080CZ, Lot Number 4136575;  101/860/080CZ, Lot Number 4165613;  101/860/080CZ, Lot Number 4165614;  101/860/080CZ, Lot Number 4170920;  101/860/080CZ, Lot Number 4178020;  101/860/080CZ, Lot Number 4179046;  101/860/080CZ, Lot Number 4183972;  101/860/080CZ, Lot Number 4186574;  101/860/080CZ, Lot Number 4186575;  101/860/080CZ, Lot Number 4189343;  101/860/080CZ, Lot Number 4191167;  101/860/080CZ, Lot Number 4191168;  101/860/080CZ, Lot Number 4195032;  101/860/080CZ, Lot Number 4202463;  101/860/080CZ, Lot Number 4205543;  101/860/080CZ, Lot Number 4207746;  101/860/080CZ, Lot Number 4211996;  101/860/080CZ, Lot Number 4211997;  101/860/080CZ, Lot Number 4211998;  101/860/080CZ, Lot Number 4214635;  101/860/080CZ, Lot Number 4217853;  101/860/080CZ, Lot Number 4219600;  101/860/080CZ, Lot Number 4221985;  101/860/080CZ, Lot Number 4231321;  101/860/080CZ, Lot Number 4231322;  101/860/080CZ, Lot Number 4232674;  101/860/080CZ, Lot Number 4234707;  101/860/080CZ, Lot Number 4242937;  101/860/080CZ, Lot Number 4249310;  101/860/080CZ, Lot Number 4252471;  101/860/080CZ, Lot Number 4252472;  101/860/080CZ, Lot Number 4254577;  101/860/080CZ, Lot Number 4254578;  101/860/080CZ, Lot Number 4259268;  101/860/080CZ, Lot Number 4259269;  101/860/080CZ, Lot Number 4281080;  101/860/080CZ, Lot Number 4281081;  101/860/080CZ, Lot Number 4283735;  101/860/080CZ, Lot Number 4285774;  101/860/080CZ, Lot Number 4285775;  101/860/080CZ, Lot Number 4305958;  101/860/080CZ, Lot Number 4305959;  101/860/080CZ, Lot Number 4312278;  101/860/080CZ, Lot Number 4312279;  101/860/080CZ, Lot Number 4312280;  101/860/080CZ, Lot Number 4319745;  101/860/080CZ, Lot Number 4319746;  101/860/080CZ, Lot Number 4357891;  101/860/080CZ, Lot Number 4365949;  101/860/080CZ, Lot Number 4376685;  101/860/080CZ, Lot Number 4376686;  101/860/080CZ, Lot Number 4376687;  101/860/080CZ, Lot Number 4384987;  101/860/080CZ, Lot Number 4384988;  101/860/080CZ, Lot Number 4386575; 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 101/860/090CZ, Lot Number 4306064;  101/860/090CZ, Lot Number 4310533;  101/860/090CZ, Lot Number 4382009;  101/860/090CZ, Lot Number 4385029;  101/860/100CZ, Lot Number 3895093;  101/860/100CZ, Lot Number 3925786;  101/860/100CZ, Lot Number 3951305;  101/860/100CZ, Lot Number 3968281;  101/860/100CZ, Lot Number 4010004;  101/860/100CZ, Lot Number 4025595;  101/860/100CZ, Lot Number 4054789;  101/860/100CZ, Lot Number 4199355;  101/860/100CZ, Lot Number 4217881;  101/860/100CZ, Lot Number 4285765;  101/860/100CZ, Lot Number 4412135;  101/870/060CZ, Lot Number 3887510;  101/870/060CZ, Lot Number 3925734;  101/870/060CZ, Lot Number 3951306;  101/870/060CZ, Lot Number 4031337;  101/870/060CZ, Lot Number 4106745;  101/870/060CZ, Lot Number 4217882;  101/870/070CZ, Lot Number 3889311;  101/870/070CZ, Lot Number 3951204;  101/870/070CZ, Lot Number 3968404;  101/870/070CZ, Lot Number 4017237;  101/870/070CZ, Lot Number 4022711;  101/870/070CZ, Lot Number 4034792;  101/870/070CZ, Lot Number 4058662;  101/870/070CZ, Lot Number 4073762;  101/870/070CZ, Lot Number 4134828;  101/870/070CZ, Lot Number 4138214;  101/870/070CZ, Lot Number 4156953;  101/870/070CZ, Lot Number 4165744;  101/870/070CZ, Lot Number 4178001;  101/870/070CZ, Lot Number 4217826;  101/870/070CZ, Lot Number 4249291;  101/870/070CZ, Lot Number 4256336;  101/870/070CZ, Lot Number 4283719;  101/870/070CZ, Lot Number 4291171;  101/870/075CZ, Lot Number 3906881;  101/870/075CZ, Lot Number 3951207;  101/870/075CZ, Lot Number 3968405;  101/870/075CZ, Lot Number 4054813;  101/870/075CZ, Lot Number 4058606;  101/870/075CZ, Lot Number 4061022;  101/870/075CZ, Lot Number 4134829;  101/870/075CZ, Lot Number 4138176;  101/870/075CZ, Lot Number 4183954;  101/870/075CZ, Lot Number 4212004;  101/870/075CZ, Lot Number 4238185;  101/870/075CZ, Lot Number 4249236;  101/870/075CZ, Lot Number 4270941;  101/870/075CZ, Lot Number 4276631;  101/870/075CZ, Lot Number 4382010;  101/870/080CZ, Lot Number 3887515;  101/870/080CZ, Lot Number 3951288;  101/870/080CZ, Lot Number 3980351;  101/870/080CZ, Lot Number 3989180;  101/870/080CZ, Lot Number 4017250;  101/870/080CZ, Lot Number 4051928;  101/870/080CZ, Lot Number 4054796;  101/870/080CZ, Lot Number 4070522;  101/870/080CZ, Lot Number 4117931;  101/870/080CZ, Lot Number 4134866;  101/870/080CZ, Lot Number 4138056;  101/870/080CZ, Lot Number 4156930;  101/870/080CZ, Lot Number 4163106;  101/870/080CZ, Lot Number 4208997;  101/870/080CZ, Lot Number 4238168;  101/870/080CZ, Lot Number 4254564;  101/870/080CZ, Lot Number 4303380;  101/870/080CZ, Lot Number 4310523;  101/870/080CZ, Lot Number 4312285;  101/870/080CZ, Lot Number 4317581;  101/870/080CZ, Lot Number 4319800;  101/870/080CZ, Lot Number 4368642;  101/870/080CZ, Lot Number 4388736;  101/870/080CZ, Lot Number 4390747;  101/870/085CZ, Lot Number 3887484;  101/870/085CZ, Lot Number 3925788;  101/870/085CZ, Lot Number 4002986;  101/870/085CZ, Lot Number 4054842;  101/870/085CZ, Lot Number 4085217;  101/870/085CZ, Lot Number 4110784;  101/870/085CZ, Lot Number 4121517;  101/870/085CZ, Lot Number 4156983;  101/870/085CZ, Lot Number 4183981;  101/870/085CZ, Lot Number 4212070;  101/870/085CZ, Lot Number 4245285;  101/870/085CZ, Lot Number 4249238;  101/870/085CZ, Lot Number 4376585;  101/870/090CZ, Lot Number 3892136;  101/870/090CZ, Lot Number 3907683;  101/870/090CZ, Lot Number 3951191;  101/870/090CZ, Lot Number 3962340;  101/870/090CZ, Lot Number 4000188;  101/870/090CZ, Lot Number 4061185;  101/870/090CZ, Lot Number 4075797;  101/870/090CZ, Lot Number 4106832;  101/870/090CZ, Lot Number 4129451;  101/870/090CZ, Lot Number 4138105;  101/870/090CZ, Lot Number 4155508;  101/870/090CZ, Lot Number 4178002;  101/870/090CZ, Lot Number 4183974;  101/870/090CZ, Lot Number 4242948;  101/870/090CZ, Lot Number 4249307;  101/870/090CZ, Lot Number 4249334;  101/870/090CZ, Lot Number 4276656;  101/870/090CZ, Lot Number 4285763;  101/870/090CZ, Lot Number 4285764;  101/870/090CZ, Lot Number 4303381;  101/870/090CZ, Lot Number 4387367;  101/870/100CZ, Lot Number 3887465;  101/870/100CZ, Lot Number 3925771;  101/870/100CZ, Lot Number 3996000;  101/870/100CZ, Lot Number 4075798;  101/870/100CZ, Lot Number 4087868;  101/870/100CZ, Lot Number 4106718;  101/870/100CZ, Lot Number 4209008;  101/870/100CZ, Lot Number 4217806;  101/870/100CZ, Lot Number 4245461;  101/870/100CZ, Lot Number 4256343;  101/870/100CZ, Lot Number 4306010;  101/875/060, Lot Number 3973580;  101/875/060, Lot Number 3994206;  101/875/060, Lot Number 4077390;  101/875/060, Lot Number 4077409;  101/875/060, Lot Number 4097405;  101/875/060, Lot Number 4106652;  101/875/060, Lot Number 4121852;  101/875/060, Lot Number 4174792;  101/875/060, Lot Number 4185328;  101/875/060, Lot Number 4228918;  101/875/060, Lot Number 4294942;  101/875/060, Lot Number 4306861;  101/875/070, Lot Number 3965241;  101/875/070, Lot Number 3997476;  101/875/070, Lot Number 4040743;  101/875/070, Lot Number 4040744;  101/875/070, Lot Number 4040748;  101/875/070, Lot Number 4083147;  101/875/070, Lot Number 4090267;  101/875/070, Lot Number 4106653;  101/875/070, Lot Number 4106657;  101/875/070, Lot Number 4130528;  101/875/070, Lot Number 4219470;  101/875/070, Lot Number 4244044;  101/875/070, Lot Number 4244045;  101/875/075, Lot Number 3956207;  101/875/075, Lot Number 3965238;  101/875/075, Lot Number 4106984;  101/875/075, Lot Number 4230803;  101/875/075, Lot Number 4294936;  101/875/075, Lot Number 4318743;  101/875/075, Lot Number 4380983;  101/875/080, Lot Number 3905060;  101/875/080, Lot Number 4038638;  101/875/080, Lot Number 4071393;  101/875/080, Lot Number 4083162;  101/875/080, Lot Number 4088887;  101/875/080, Lot Number 4091522;  101/875/080, Lot Number 4106655;  101/875/080, Lot Number 4124771;  101/875/080, Lot Number 4187079;  101/875/080, Lot Number 4187084;  101/875/080, Lot Number 4202304;  101/875/080, Lot Number 4220404;  101/875/080, Lot Number 4279527;  101/875/080, Lot Number 4294941;  101/875/080, Lot Number 4375952;  101/875/085, Lot Number 3956339;  101/875/085, Lot Number 4106981;  101/875/085, Lot Number 4119879;  101/875/085, Lot Number 4187077;  101/875/085, Lot Number 4202297;  101/875/085, Lot Number 4216554;  101/875/090, Lot Number 4034431;  101/875/090, Lot Number 4067217;  101/875/090, Lot Number 4068186;  101/875/090, Lot Number 4106650;  101/875/090, Lot Number 4106999;  101/875/090, Lot Number 4115631;  101/875/090, Lot Number 4118290;  101/875/090, Lot Number 4187086;  101/875/090, Lot Number 4206467;  101/875/090, Lot Number 4216550;  101/875/090, Lot Number 4220407;  101/875/100, Lot Number 3905062",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}