{
  "@context": {
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    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
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    "occurred": "au:occurred",
    "supported": "au:supported",
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    "grounding": "au:grounding",
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    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
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    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0818-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Procedural convenience kits and trays, cardiac, labeled as:    a)\tEP LAB BI V IMPLANT PACK, kit number AGBI64J;   b)\tLAB DEVICE IMPLANT, kit number AGDI40J;   c)\tLAB DEVICE IMPLANT, kit number AGDI40K;   d)\tMINOR VASCULAR, kit number AGMV26O;   e)\tOPEN HEART ACCESSORY, kit number AGOH98Q;   f)\tOPEN HEART ACCESSORY, kit number AGOH98R;   g)\tOPEN HEART ACCESSORY, kit number AGOH98S;   h)\tPERIPHERAL VASCULAR, kit number AGPV28O;   i)\tPERIPHERAL VASCULAR, kit number AGPV28P;   j)\tMINOR VASCULAR, kit number AHMV26J;   k)\tMINOR VASCULAR, kit number AHMV26K;   l)\tHEART PACK - 205947, kit number ANCV78AX;   m)\tHEART PACK - 205947 , kit number ANCV78AX1;   n)\tHEART PACK - 205947 Post Open-Heart, kit number ANHK74N;   o)\tOPEN HEART EAST PACK, kit number BHOH43;   p)\t74OFF PUMP CABG PACK, kit number BHOP48;   q)\tPACEMAKER PACK, kit number BHPM60;   r)\tFORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K;   s)\tT AND A PACK AGH ASC, kit number FBDI42L;   t)\tT AND A PACK AGH ASC, kit number FBDI42M;   u)\tTHORACOSCOPY PACK, kit number FBTO60G;   v)\tOPEN HEART ACCESSORY PACK, kit number JROH00O;   w)\tOPEN HEART ACCESSORY PACK, kit number JROH98O;   x)\tADULT OPEN HEART PACK, kit number LLOH52;   y)\tADULT OPEN HEART PACK, kit number LLOP25;   z)\tPACEMAKER PACK, kit number LLPP14;   aa)\tHEART PACK, kit number LMCB06AD;   bb)\tCARDIAC HEART BUNDLE NS, kit number LMCH99O;   cc)\tOPEN HEAART PACK, kit number LMOH50AD;   dd)\tOPEN HEAART PACK, kit number LMOH50AD-01;   ee)\tOPEN HEAART PACK, kit number LMOH50AD-02;   ff)\tOPEN HEAART PACK, kit number LMOH50AE;   gg)\tCV PACK, kit number MMCV98V;   hh)\tCV PACK, kit number MMCV98V-03;   ii)\tCV PACK, kit number MMCV98V-04;   jj)\tKIT OPEN HEART ADULT, kit number MMOH64J;   kk)\tPACEMAKER PACK, kit number MMPM27E;   ll)\tKIT, THORACOTOMY UNIVERSAL, kit number MMTR12F;   mm)\tANT CERV FUSION PACK, kit number NCAC96;   nn)\tOPEN HEART- ACCESSOR, kit number NCOH11;   oo)\tVASCULAR SAH, kit number SAVA91G;   pp)\tVASCULAR SAH, kit number SAVA91H;   qq)\tVASCULAR SAH, kit number SAVA91I;   rr)\tVASCULAR SAH, kit number SAVA91J;   ss)\tOPEN HEART BRINGBACK SJH, kit number SJOH17I;   tt)\tOPEN HEART CV SJH, kit number SJOH28L;   uu)\tPEDIATRIC HEART SJH, kit number SJPH34K;   vv)\tVASC OPEN CVOR SJH, kit number SJVO56A;   ww)\tVASC OPEN CVOR SJH, kit number SJVO56B;   xx)\tMAJOR CV TRAY, kit number SVMJ20L;   yy)\tMAJOR CV TRAY, kit number SVMJ20M;   zz)\tMINOR CV TRAY¿, kit number SVMN60J;   aaa)\tOPEN HEART COMPONENT PACK, kit number SVOH38Q;   bbb)\tCV B PACK, kit number TNCB10AK;   ccc)\tCARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM",
  "description": "FDA recall Z-0818-2024 — American Contract Systems, Inc. is recalling Procedural convenience kits and trays, cardiac, labeled as:    a)\tEP LAB BI V IMPLANT PACK, kit number AGBI64J;   b)\tLAB DEVICE IMPLANT, kit number AGDI40J;   c)\tLAB DEVICE IMPLANT, kit number AGDI40K;   d)\tMINOR VASCULAR, kit number AGMV26O;   e)\tOPEN HEART ACCESSORY, kit number AGOH98Q;   f)\tOPEN HEART ACCESSORY, kit number AGOH98R;   g)\tOPEN HEART ACCESSORY, kit number AGOH98S;   h)\tPERIPHERAL VASCULAR, kit number AGPV28O;   i)\tPERIPHERAL VASCULAR, kit number AGPV28P;   j)\tMINOR VASCULAR, kit number AHMV26J;   k)\tMINOR VASCULAR, kit number AHMV26K;   l)\tHEART PACK - 205947, kit number ANCV78AX;   m)\tHEART PACK - 205947 , kit number ANCV78AX1;   n)\tHEART PACK - 205947 Post Open-Heart, kit number ANHK74N;   o)\tOPEN HEART EAST PACK, kit number BHOH43;   p)\t74OFF PUMP CABG PACK, kit number BHOP48;   q)\tPACEMAKER PACK, kit number BHPM60;   r)\tFORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K;   s)\tT AND A PACK AGH ASC, kit number FBDI42L;   t)\tT AND A PACK AGH ASC, kit number FBDI42M;   u)\tTHORACOSCOPY PACK, kit number FBTO60G;   v)\tOPEN HEART ACCESSORY PACK, kit number JROH00O;   w)\tOPEN HEART ACCESSORY PACK, kit number JROH98O;   x)\tADULT OPEN HEART PACK, kit number LLOH52;   y)\tADULT OPEN HEART PACK, kit number LLOP25;   z)\tPACEMAKER PACK, kit number LLPP14;   aa)\tHEART PACK, kit number LMCB06AD;   bb)\tCARDIAC HEART BUNDLE NS, kit number LMCH99O;   cc)\tOPEN HEAART PACK, kit number LMOH50AD;   dd)\tOPEN HEAART PACK, kit number LMOH50AD-01;   ee)\tOPEN HEAART PACK, kit number LMOH50AD-02;   ff)\tOPEN HEAART PACK, kit number LMOH50AE;   gg)\tCV PACK, kit number MMCV98V;   hh)\tCV PACK, kit number MMCV98V-03;   ii)\tCV PACK, kit number MMCV98V-04;   jj)\tKIT OPEN HEART ADULT, kit number MMOH64J;   kk)\tPACEMAKER PACK, kit number MMPM27E;   ll)\tKIT, THORACOTOMY UNIVERSAL, kit number MMTR12F;   mm)\tANT CERV FUSION PACK, kit number NCAC96;   nn)\tOPEN HEART- ACCESSOR, kit number NCOH11;   oo)\tVASCULAR SAH, kit number SAVA91G;   pp)\tVASCULAR SAH, kit number SAVA91H;   qq)\tVASCULAR SAH, kit number SAVA91I;   rr)\tVASCULAR SAH, kit number SAVA91J;   ss)\tOPEN HEART BRINGBACK SJH, kit number SJOH17I;   tt)\tOPEN HEART CV SJH, kit number SJOH28L;   uu)\tPEDIATRIC HEART SJH, kit number SJPH34K;   vv)\tVASC OPEN CVOR SJH, kit number SJVO56A;   ww)\tVASC OPEN CVOR SJH, kit number SJVO56B;   xx)\tMAJOR CV TRAY, kit number SVMJ20L;   yy)\tMAJOR CV TRAY, kit number SVMJ20M;   zz)\tMINOR CV TRAY¿, kit number SVMN60J;   aaa)\tOPEN HEART COMPONENT PACK, kit number SVOH38Q;   bbb)\tCV B PACK, kit number TNCB10AK;   ccc)\tCARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM (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-0818-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Procedural convenience kits and trays, cardiac, labeled as:    a)\tEP LAB BI V IMPLANT PACK, kit number AGBI64J;   b)\tLAB DEVICE IMPLANT, kit number AGDI40J;   c)\tLAB DEVICE IMPLANT, kit number AGDI40K;   d)\tMINOR VASCULAR, kit number AGMV26O;   e)\tOPEN HEART ACCESSORY, kit number AGOH98Q;   f)\tOPEN HEART ACCESSORY, kit number AGOH98R;   g)\tOPEN HEART ACCESSORY, kit number AGOH98S;   h)\tPERIPHERAL VASCULAR, kit number AGPV28O;   i)\tPERIPHERAL VASCULAR, kit number AGPV28P;   j)\tMINOR VASCULAR, kit number AHMV26J;   k)\tMINOR VASCULAR, kit number AHMV26K;   l)\tHEART PACK - 205947, kit number ANCV78AX;   m)\tHEART PACK - 205947 , kit number ANCV78AX1;   n)\tHEART PACK - 205947 Post Open-Heart, kit number ANHK74N;   o)\tOPEN HEART EAST PACK, kit number BHOH43;   p)\t74OFF PUMP CABG PACK, kit number BHOP48;   q)\tPACEMAKER PACK, kit number BHPM60;   r)\tFORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K;   s)\tT AND A PACK AGH ASC, kit number FBDI42L;   t)\tT AND A PACK AGH ASC, kit number FBDI42M;   u)\tTHORACOSCOPY PACK, kit number FBTO60G;   v)\tOPEN HEART ACCESSORY PACK, kit number JROH00O;   w)\tOPEN HEART ACCESSORY PACK, kit number JROH98O;   x)\tADULT OPEN HEART PACK, kit number LLOH52;   y)\tADULT OPEN HEART PACK, kit number LLOP25;   z)\tPACEMAKER PACK, kit number LLPP14;   aa)\tHEART PACK, kit number LMCB06AD;   bb)\tCARDIAC HEART BUNDLE NS, kit number LMCH99O;   cc)\tOPEN HEAART PACK, kit number LMOH50AD;   dd)\tOPEN HEAART PACK, kit number LMOH50AD-01;   ee)\tOPEN HEAART PACK, kit number LMOH50AD-02;   ff)\tOPEN HEAART PACK, kit number LMOH50AE;   gg)\tCV PACK, kit number MMCV98V;   hh)\tCV PACK, kit number MMCV98V-03;   ii)\tCV PACK, kit number MMCV98V-04;   jj)\tKIT OPEN HEART ADULT, kit number MMOH64J;   kk)\tPACEMAKER PACK, kit number MMPM27E;   ll)\tKIT, THORACOTOMY UNIVERSAL, kit number MMTR12F;   mm)\tANT CERV FUSION PACK, kit number NCAC96;   nn)\tOPEN HEART- ACCESSOR, kit number NCOH11;   oo)\tVASCULAR SAH, kit number SAVA91G;   pp)\tVASCULAR SAH, kit number SAVA91H;   qq)\tVASCULAR SAH, kit number SAVA91I;   rr)\tVASCULAR SAH, kit number SAVA91J;   ss)\tOPEN HEART BRINGBACK SJH, kit number SJOH17I;   tt)\tOPEN HEART CV SJH, kit number SJOH28L;   uu)\tPEDIATRIC HEART SJH, kit number SJPH34K;   vv)\tVASC OPEN CVOR SJH, kit number SJVO56A;   ww)\tVASC OPEN CVOR SJH, kit number SJVO56B;   xx)\tMAJOR CV TRAY, kit number SVMJ20L;   yy)\tMAJOR CV TRAY, kit number SVMJ20M;   zz)\tMINOR CV TRAY¿, kit number SVMN60J;   aaa)\tOPEN HEART COMPONENT PACK, kit number SVOH38Q;   bbb)\tCV B PACK, kit number TNCB10AK;   ccc)\tCARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0818-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0818-2024: American Contract Systems, Inc. is recalling Procedural convenience kits and trays, cardiac, labeled as:    a)\tEP LAB BI V IMPLANT PACK, kit number AGBI64J;   b)\tLAB DEVICE IMPLANT, kit number AGDI40J;   c)\tLAB DEVICE IMPLANT, kit number AGDI40K;   d)\tMINOR VASCULAR, kit number AGMV26O;   e)\tOPEN HEART ACCESSORY, kit number AGOH98Q;   f)\tOPEN HEART ACCESSORY, kit number AGOH98R;   g)\tOPEN HEART ACCESSORY, kit number AGOH98S;   h)\tPERIPHERAL VASCULAR, kit number AGPV28O;   i)\tPERIPHERAL VASCULAR, kit number AGPV28P;   j)\tMINOR VASCULAR, kit number AHMV26J;   k)\tMINOR VASCULAR, kit number AHMV26K;   l)\tHEART PACK - 205947, kit number ANCV78AX;   m)\tHEART PACK - 205947 , kit number ANCV78AX1;   n)\tHEART PACK - 205947 Post Open-Heart, kit number ANHK74N;   o)\tOPEN HEART EAST PACK, kit number BHOH43;   p)\t74OFF PUMP CABG PACK, kit number BHOP48;   q)\tPACEMAKER PACK, kit number BHPM60;   r)\tFORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K;   s)\tT AND A PACK AGH ASC, kit number FBDI42L;   t)\tT AND A PACK AGH ASC, kit number FBDI42M;   u)\tTHORACOSCOPY PACK, kit number FBTO60G;   v)\tOPEN HEART ACCESSORY PACK, kit number JROH00O;   w)\tOPEN HEART ACCESSORY PACK, kit number JROH98O;   x)\tADULT OPEN HEART PACK, kit number LLOH52;   y)\tADULT OPEN HEART PACK, kit number LLOP25;   z)\tPACEMAKER PACK, kit number LLPP14;   aa)\tHEART PACK, kit number LMCB06AD;   bb)\tCARDIAC HEART BUNDLE NS, kit number LMCH99O;   cc)\tOPEN HEAART PACK, kit number LMOH50AD;   dd)\tOPEN HEAART PACK, kit number LMOH50AD-01;   ee)\tOPEN HEAART PACK, kit number LMOH50AD-02;   ff)\tOPEN HEAART PACK, kit number LMOH50AE;   gg)\tCV PACK, kit number MMCV98V;   hh)\tCV PACK, kit number MMCV98V-03;   ii)\tCV PACK, kit number MMCV98V-04;   jj)\tKIT OPEN HEART ADULT, kit number MMOH64J;   kk)\tPACEMAKER PACK, kit number MMPM27E;   ll)\tKIT, THORACOTOMY UNIVERSAL, kit number MMTR12F;   mm)\tANT CERV FUSION PACK, kit number NCAC96;   nn)\tOPEN HEART- ACCESSOR, kit number NCOH11;   oo)\tVASCULAR SAH, kit number SAVA91G;   pp)\tVASCULAR SAH, kit number SAVA91H;   qq)\tVASCULAR SAH, kit number SAVA91I;   rr)\tVASCULAR SAH, kit number SAVA91J;   ss)\tOPEN HEART BRINGBACK SJH, kit number SJOH17I;   tt)\tOPEN HEART CV SJH, kit number SJOH28L;   uu)\tPEDIATRIC HEART SJH, kit number SJPH34K;   vv)\tVASC OPEN CVOR SJH, kit number SJVO56A;   ww)\tVASC OPEN CVOR SJH, kit number SJVO56B;   xx)\tMAJOR CV TRAY, kit number SVMJ20L;   yy)\tMAJOR CV TRAY, kit number SVMJ20M;   zz)\tMINOR CV TRAY¿, kit number SVMN60J;   aaa)\tOPEN HEART COMPONENT PACK, kit number SVOH38Q;   bbb)\tCV B PACK, kit number TNCB10AK;   ccc)\tCARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM",
      "text": "The FDA logged enforcement record Z-0818-2024: American Contract Systems, Inc. is voluntarily recalling Procedural convenience kits and trays, cardiac, labeled as:    a)\tEP LAB BI V IMPLANT PACK, kit number AGBI64J;   b)\tLAB DEVICE IMPLANT, kit number AGDI40J;   c)\tLAB DEVICE IMPLANT, kit number AGDI40K;   d)\tMINOR VASCULAR, kit number AGMV26O;   e)\tOPEN HEART ACCESSORY, kit number AGOH98Q;   f)\tOPEN HEART ACCESSORY, kit number AGOH98R;   g)\tOPEN HEART ACCESSORY, kit number AGOH98S;   h)\tPERIPHERAL VASCULAR, kit number AGPV28O;   i)\tPERIPHERAL VASCULAR, kit number AGPV28P;   j)\tMINOR VASCULAR, kit number AHMV26J;   k)\tMINOR VASCULAR, kit number AHMV26K;   l)\tHEART PACK - 205947, kit number ANCV78AX;   m)\tHEART PACK - 205947 , kit number ANCV78AX1;   n)\tHEART PACK - 205947 Post Open-Heart, kit number ANHK74N;   o)\tOPEN HEART EAST PACK, kit number BHOH43;   p)\t74OFF PUMP CABG PACK, kit number BHOP48;   q)\tPACEMAKER PACK, kit number BHPM60;   r)\tFORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K;   s)\tT AND A PACK AGH ASC, kit number FBDI42L;   t)\tT AND A PACK AGH ASC, kit number FBDI42M;   u)\tTHORACOSCOPY PACK, kit number FBTO60G;   v)\tOPEN HEART ACCESSORY PACK, kit number JROH00O;   w)\tOPEN HEART ACCESSORY PACK, kit number JROH98O;   x)\tADULT OPEN HEART PACK, kit number LLOH52;   y)\tADULT OPEN HEART PACK, kit number LLOP25;   z)\tPACEMAKER PACK, kit number LLPP14;   aa)\tHEART PACK, kit number LMCB06AD;   bb)\tCARDIAC HEART BUNDLE NS, kit number LMCH99O;   cc)\tOPEN HEAART PACK, kit number LMOH50AD;   dd)\tOPEN HEAART PACK, kit number LMOH50AD-01;   ee)\tOPEN HEAART PACK, kit number LMOH50AD-02;   ff)\tOPEN HEAART PACK, kit number LMOH50AE;   gg)\tCV PACK, kit number MMCV98V;   hh)\tCV PACK, kit number MMCV98V-03;   ii)\tCV PACK, kit number MMCV98V-04;   jj)\tKIT OPEN HEART ADULT, kit number MMOH64J;   kk)\tPACEMAKER PACK, kit number MMPM27E;   ll)\tKIT, THORACOTOMY UNIVERSAL, kit number MMTR12F;   mm)\tANT CERV FUSION PACK, kit number NCAC96;   nn)\tOPEN HEART- ACCESSOR, kit number NCOH11;   oo)\tVASCULAR SAH, kit number SAVA91G;   pp)\tVASCULAR SAH, kit number SAVA91H;   qq)\tVASCULAR SAH, kit number SAVA91I;   rr)\tVASCULAR SAH, kit number SAVA91J;   ss)\tOPEN HEART BRINGBACK SJH, kit number SJOH17I;   tt)\tOPEN HEART CV SJH, kit number SJOH28L;   uu)\tPEDIATRIC HEART SJH, kit number SJPH34K;   vv)\tVASC OPEN CVOR SJH, kit number SJVO56A;   ww)\tVASC OPEN CVOR SJH, kit number SJVO56B;   xx)\tMAJOR CV TRAY, kit number SVMJ20L;   yy)\tMAJOR CV TRAY, kit number SVMJ20M;   zz)\tMINOR CV TRAY¿, kit number SVMN60J;   aaa)\tOPEN HEART COMPONENT PACK, kit number SVOH38Q;   bbb)\tCV B PACK, kit number TNCB10AK;   ccc)\tCARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM — reason: During an internal investigation, ACS identified that several components were \"piggybacked\" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the \"piggybacked\" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the  piggybacked  components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-29. Affected lots/codes: a) AGBI64J, UDI/DI 0019107247578, Lot numbers:  956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 699221, exp. 10/28/2023; 727221, exp. 9/30/2023; 731221, exp. 9/26/2023; 769221, exp. 8/19/2023; 876221, exp. 5/4/2023;   b) AGDI40J, UDI/DI 00191072154668, Lot numbers:  956231, exp. 7/31/2023; 647221, exp. 7/31/2023; 708221, exp. 7/31/2023; 750221, exp. 7/31/2023;  c) AGDI40K, UDI/DI 00191072188168, Lot numbers:  910231, exp. 3/31/2024; 904231, exp. 4/6/2024;  d) AGMV26O, UDI/DI 00191072179777, Lot numbers:  900231, exp. 2/23/2024; 912231, exp. 2/23/2024; 949231, exp. 2/20/2023; 982231, exp. 1/18/2024; 666221, exp. 11/30/2023; 713221, exp. 10/14/2023; 763221, exp. 8/25/2023; 822221, exp. 6/27/2023; e) AGOH98Q, UDI/DI 00191072159419, Lot numbers:  846221, exp. 6/3/2023;  f) AGOH98R, UDI/DI 00191072169754, Lot numbers: 742221, exp. 9/15/2023; 772221, exp. 8/16/2023; 794221, exp. 7/25/2023;   g) AGOH98S, UDI/DI 00191072179784, Lot numbers:  921231, exp. 7/31/2023; 636221, exp. 10/10/2023; 685221, exp. 11/11/2023; 707221, exp. 7/31/2023; 729221, exp. 7/31/2023; h) AGPV28O, UDI/D I00191072137210, Lot numbers:  847221, exp. 6/2/2023;  i) AGPV28P, UDI/DI 00191072179791, Lot numbers:  771221, exp. 8/17/2023; 961231, exp. 2/8/2024; 696221, exp. 10/31/2023;  j) AHMV26J, UDI/DI 00191072137586, Lot numbers:  735221, exp. 9/22/2023; 790221, exp. 7/29/2023; 839221, exp. 6/10/2023;  k) AHMV26K, UDI/DI 00191072179807, Lot numbers:  896231, exp. 4/14/2024; 977231, exp. 1/23/2024; 953231, exp. 2/16/2024; 969231, exp. 1/31/2024; 686221, exp. 11/10/2023; 721221, exp. 10/6/2023;  l) ANCV78AX, UDI/DI 00191072182692, Lot numbers: 706221, exp. 10/21/2023;  m) ANCV78AX1, UDI/DI 00191072182692, Lot numbers:  647221, exp. 12/19/2023;  n) ANHK74N, UDI/DI 00191072191472, Lot numbers:  706221, exp. 10/21/2023;  o) BHOH43, UDI/DI 00191072160690, Lot numbers:  960231, exp. 2/9/2023; 668221, exp. 11/28/2023; 734221, exp. 9/23/2023; 773221, exp. 8/15/2023; 828221, exp. 6/21/2023; 876221, exp. 5/4/2023; 902221, exp. 4/8/2023;  p) BHOP48, UDI/DI 00191072164131, Lot numbers:  921231, exp. 3/20/2024; 948231, exp. 2/21/2024; 984231, exp. 1/16/2024; 783221, exp. 8/5/2023; 688221, exp. 1/8/2023; 736221, exp. 9/12/2023; 833221, exp. 6/16/2023; 867221, exp. 5/13/2023; 903221, exp. 4/7/2023;  q) BHPM60, UDI/DI 00191072160799, Lot numbers:  928231, exp. 3/13/2024; 968231, exp. 2/1/2024; 651221, exp. 12/15/2023; 702221, exp. 10/25/2023; 762221, exp. 8/26/2023; 836221, exp. 6/13/2023; 883221, exp. 4/27/2023;  r) FBDI42K, UDI/DI 00191072169761, Lot numbers:  976231, exp. 7/31/2023; 644221, exp. 7/31/2023; 678221, exp. 7/31/2023; 716221, exp. 7/31/2023; 743221, exp. 7/31/2023; 758221, exp. 7/31/2023; 828221, exp. 6/21/2023; 846221, exp. 6/3/2023;  s) FBDI42L, UDI/DI 00191072189905, Lot numbers:  920231, exp. 7/31/2023; 942231, exp. 7/31/2023;  t) FBDI42M, UDI/DI 00191072192066, Lot numbers:  899231, exp. 4/11/2024;  u) FBTO60G, UDI/DI 00191072164219, Lot numbers:  654221, exp. 12/12/2023; 689221, exp. 11/7/2023;  v) JROH00O, UDI/DI 00191072179814, Lot numbers:  906231, exp. 4/4/2024; 932231, exp. 3/9/2024; 935231, exp. 8/21/2023; 968231, exp. 2/1/2024; 988231, exp. 12/9/2023;  w) JROH98O, UDI/DI 00191072179821, Lot numbers:  900231, exp. 4/10/2024; 657221, exp. 11/18/2023; 686221, exp. 10/14/2023; 713221, exp. 9/14/2023;  x) LLOH52, UDI/DI 00191072169785, Lot numbers:  729221, exp. 9/28/2023; 722221, exp. 10/5/2023; 668221, exp. 11/28/2023; 980231, exp. 1/20/2024; 903231, exp. 4/7/2024;  y) LLOP25, UDI/DI 00191072167347, Lot numbers:  766221, exp. 8/22/2023; 729221, exp. 9/28/2023;  z) LLPP14, UDI/DI 00191072167354, Lot numbers:  741221, exp. 9/16/2023; 695221, exp. 11/1/2023; 639221, exp. 12/27/2023; 940231, exp. 3/1/2024;  aa) LMCB06AD, UDI/DI none, Lot numbers: 721221, exp. 10/6/2023; 675221, exp. 11/21/2023; 927231, exp. 3/14/2024; 890231, exp. 4/20/2024;   bb) LMCH99O, UDI/DI none, Lot numbers:  762221, exp. 8/26/2023; 715221, exp. 10/12/2023; 674221, exp. 11/22/2023; 872231, exp. 5/8/2024;  cc) LMOH50AD, UDI/DI 00191072165534, Lot numbers:  847221, exp. 6/2/2023; 833221, exp. 6/16/2023; 807221, exp. 7/12/2023; 751221, exp. 8/27/2023;  dd) LMOH50AD-01, UDI/DI 0019107216553 , Lot numbers:  878221, exp. 5/2/2023; 765221, exp. 8/23/2023;  ee) LMOH50AD-02, UDI/DI 00191072165534, Lot numbers:  731221, exp. 9/26/2023; 682221, exp. 11/14/2023;  ff) LMOH50AE, UDI/DI 00191072184443, Lot numbers:  973231, exp. 1/27/2024;  gg) MMCV98V, UDI/DI 00191072155481, Lot numbers:  867221, exp. 5/13/2023; 828221, exp. 6/21/2023; 949231, exp. 2/20/2024;  hh) MMCV98V-03, UDI/DI 00191072155481, Lot numbers:  783221, exp. 8/5/2023;  ii) MMCV98V-04, UDI/DI 00191072155481, Lot numbers:  681221, exp. 11/15/2023;  jj) MMOH64J, UDI/DI none, Lot numbers:  933231, exp. 3/8/2024; 871231, exp. 5/9/2024;  kk) MMPM27E, UDI/DI none, Lot numbers:  935231, exp. 3/6/2024;  ll) MMTR12F, UDI/DI none, Lot numbers:  889231, exp. 4/21/2024;  mm) NCAC96, UDI/DI 00191072016829, Lot numbers:  963231, exp. 8/18/2023; 996231, exp. 6/2/2023; 715221, exp. 6/2/2023; 811221, exp. 6/2/2023; 863221, exp. 5/17/2023;  nn) NCOH11, UDI/DI 00191072160867, Lot numbers:  956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 751221, exp. 4/6/2023; 827221, exp. 6/22/2023; 864221, exp. 5/16/2023;  oo) SAVA91G, UDI/DI none, Lot numbers:  824221, exp. 6/25/2023; 870221, exp. 5/10/2023;  pp) SAVA91H, UDI/DI none, Lot numbers:  790221, exp. 7/29/2023;  qq) SAVA91I, UDI/DI none, Lot numbers:  702221, exp. 10/25/2023; 742221, exp. 9/15/2023;  rr) SAVA91J, UDI/DI none, Lot numbers:  667221, exp. 10/31/2023; 946231, exp. 2/23/2024; 989231, exp. 1/11/2024;  ss) SJOH17I, UDI/DI none, Lot numbers:  696221, exp. 10/31/2023; 747221, exp. 9/10/2023; 778221, exp. 8/10/2023; 817221, exp. 7/2/2023; 863221, exp. 5/17/2023; 988231, exp. 1/12/2024;  tt) SJOH28L, UDI/DI none, Lot numbers:  650221, exp. 12/16/2023; 702221, exp. 10/25/2023; 744221, exp. 9/13/2023; 792221, exp. 7/27/2023; 838221, exp. 6/11/2023; 888221, exp. 4/22/2023; 961231, exp. 2/8/2024; 918231, exp. 3/23/2024;  uu) SJPH34K, UDI/DI none, Lot numbers:  678221, exp. 11/18/2023; 750221, exp. 9/7/2023; 818221, exp. 7/1/2023; 975231, exp. 1/25/2024;  vv) SJVO56A, UDI/DI none, Lot numbers:  763221, exp. 8/25/2023;  ww) SJVO56B, UDI/DI none, Lot numbers:  636221, exp. 12/30/2023; 661221, exp. 12/5/2023; 686221, exp. 11/10/2023; 707221, exp. 10/20/2023; 911231, exp. 3/30/2024; 940231, exp. 3/1/2024; 974231, exp. 1/26/2024;  xx) SVMJ20L, UDI/DI 00191072142405, Lot numbers:  737221, exp. 9/20/2023; 807221, exp. 7/12/2023; 863221, exp. 5/17/2023;  yy) SVMJ20M, UDI/DI 00191072179838, Lot numbers:  903231, exp. 4/7/2024; 955231, exp. 2/14/2024; 681221, exp. 11/15/2023;  zz) SVMN60J, UDI/DI 00191072142412, Lot numbers:  654221, exp. 12/12/2023; 734221, exp. 9/23/2023; 784221, exp. 8/4/2023; 836221, exp. 6/13/2023;  aaa) SVOH38Q, UDI/DI 00191072156488, Lot numbers:  913231, exp. 3/28/2024; 891231, exp. 4/19/2024; 953231, exp. 2/16/2024; 961231, exp. 2/8/2024; 637221, exp. 12/29/2023; 651221, exp. 12/15/2023; 710221, exp. 10/17/2023; 729221, exp. 9/28/2023; 784221, exp. 7/31/2023;  bbb) TNCB10AK, UDI/DI 00191072184948, Lot numbers:  995231, exp. 1/5/2024;  ccc)  UICD62AM, UDI/DI none, Lot numbers:  959231, exp. 2/10/2024; 879231, exp. 5/1/2024. 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-0818-2024&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-0818-2024&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-0818-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0818-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "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-0818-2024&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-0818-2024&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-0818-2024/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-0818-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0818-2024",
            "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 II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "American Contract Systems, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "During an internal investigation, ACS identified that several components were \"piggybacked\" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the \"piggybacked\" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the  piggybacked  components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-29",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) AGBI64J, UDI/DI 0019107247578, Lot numbers:  956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 699221, exp. 10/28/2023; 727221, exp. 9/30/2023; 731221, exp. 9/26/2023; 769221, exp. 8/19/2023; 876221, exp. 5/4/2023;   b) AGDI40J, UDI/DI 00191072154668, Lot numbers:  956231, exp. 7/31/2023; 647221, exp. 7/31/2023; 708221, exp. 7/31/2023; 750221, exp. 7/31/2023;  c) AGDI40K, UDI/DI 00191072188168, Lot numbers:  910231, exp. 3/31/2024; 904231, exp. 4/6/2024;  d) AGMV26O, UDI/DI 00191072179777, Lot numbers:  900231, exp. 2/23/2024; 912231, exp. 2/23/2024; 949231, exp. 2/20/2023; 982231, exp. 1/18/2024; 666221, exp. 11/30/2023; 713221, exp. 10/14/2023; 763221, exp. 8/25/2023; 822221, exp. 6/27/2023; e) AGOH98Q, UDI/DI 00191072159419, Lot numbers:  846221, exp. 6/3/2023;  f) AGOH98R, UDI/DI 00191072169754, Lot numbers: 742221, exp. 9/15/2023; 772221, exp. 8/16/2023; 794221, exp. 7/25/2023;   g) AGOH98S, UDI/DI 00191072179784, Lot numbers:  921231, exp. 7/31/2023; 636221, exp. 10/10/2023; 685221, exp. 11/11/2023; 707221, exp. 7/31/2023; 729221, exp. 7/31/2023; h) AGPV28O, UDI/D I00191072137210, Lot numbers:  847221, exp. 6/2/2023;  i) AGPV28P, UDI/DI 00191072179791, Lot numbers:  771221, exp. 8/17/2023; 961231, exp. 2/8/2024; 696221, exp. 10/31/2023;  j) AHMV26J, UDI/DI 00191072137586, Lot numbers:  735221, exp. 9/22/2023; 790221, exp. 7/29/2023; 839221, exp. 6/10/2023;  k) AHMV26K, UDI/DI 00191072179807, Lot numbers:  896231, exp. 4/14/2024; 977231, exp. 1/23/2024; 953231, exp. 2/16/2024; 969231, exp. 1/31/2024; 686221, exp. 11/10/2023; 721221, exp. 10/6/2023;  l) ANCV78AX, UDI/DI 00191072182692, Lot numbers: 706221, exp. 10/21/2023;  m) ANCV78AX1, UDI/DI 00191072182692, Lot numbers:  647221, exp. 12/19/2023;  n) ANHK74N, UDI/DI 00191072191472, Lot numbers:  706221, exp. 10/21/2023;  o) BHOH43, UDI/DI 00191072160690, Lot numbers:  960231, exp. 2/9/2023; 668221, exp. 11/28/2023; 734221, exp. 9/23/2023; 773221, exp. 8/15/2023; 828221, exp. 6/21/2023; 876221, exp. 5/4/2023; 902221, exp. 4/8/2023;  p) BHOP48, UDI/DI 00191072164131, Lot numbers:  921231, exp. 3/20/2024; 948231, exp. 2/21/2024; 984231, exp. 1/16/2024; 783221, exp. 8/5/2023; 688221, exp. 1/8/2023; 736221, exp. 9/12/2023; 833221, exp. 6/16/2023; 867221, exp. 5/13/2023; 903221, exp. 4/7/2023;  q) BHPM60, UDI/DI 00191072160799, Lot numbers:  928231, exp. 3/13/2024; 968231, exp. 2/1/2024; 651221, exp. 12/15/2023; 702221, exp. 10/25/2023; 762221, exp. 8/26/2023; 836221, exp. 6/13/2023; 883221, exp. 4/27/2023;  r) FBDI42K, UDI/DI 00191072169761, Lot numbers:  976231, exp. 7/31/2023; 644221, exp. 7/31/2023; 678221, exp. 7/31/2023; 716221, exp. 7/31/2023; 743221, exp. 7/31/2023; 758221, exp. 7/31/2023; 828221, exp. 6/21/2023; 846221, exp. 6/3/2023;  s) FBDI42L, UDI/DI 00191072189905, Lot numbers:  920231, exp. 7/31/2023; 942231, exp. 7/31/2023;  t) FBDI42M, UDI/DI 00191072192066, Lot numbers:  899231, exp. 4/11/2024;  u) FBTO60G, UDI/DI 00191072164219, Lot numbers:  654221, exp. 12/12/2023; 689221, exp. 11/7/2023;  v) JROH00O, UDI/DI 00191072179814, Lot numbers:  906231, exp. 4/4/2024; 932231, exp. 3/9/2024; 935231, exp. 8/21/2023; 968231, exp. 2/1/2024; 988231, exp. 12/9/2023;  w) JROH98O, UDI/DI 00191072179821, Lot numbers:  900231, exp. 4/10/2024; 657221, exp. 11/18/2023; 686221, exp. 10/14/2023; 713221, exp. 9/14/2023;  x) LLOH52, UDI/DI 00191072169785, Lot numbers:  729221, exp. 9/28/2023; 722221, exp. 10/5/2023; 668221, exp. 11/28/2023; 980231, exp. 1/20/2024; 903231, exp. 4/7/2024;  y) LLOP25, UDI/DI 00191072167347, Lot numbers:  766221, exp. 8/22/2023; 729221, exp. 9/28/2023;  z) LLPP14, UDI/DI 00191072167354, Lot numbers:  741221, exp. 9/16/2023; 695221, exp. 11/1/2023; 639221, exp. 12/27/2023; 940231, exp. 3/1/2024;  aa) LMCB06AD, UDI/DI none, Lot numbers: 721221, exp. 10/6/2023; 675221, exp. 11/21/2023; 927231, exp. 3/14/2024; 890231, exp. 4/20/2024;   bb) LMCH99O, UDI/DI none, Lot numbers:  762221, exp. 8/26/2023; 715221, exp. 10/12/2023; 674221, exp. 11/22/2023; 872231, exp. 5/8/2024;  cc) LMOH50AD, UDI/DI 00191072165534, Lot numbers:  847221, exp. 6/2/2023; 833221, exp. 6/16/2023; 807221, exp. 7/12/2023; 751221, exp. 8/27/2023;  dd) LMOH50AD-01, UDI/DI 0019107216553 , Lot numbers:  878221, exp. 5/2/2023; 765221, exp. 8/23/2023;  ee) LMOH50AD-02, UDI/DI 00191072165534, Lot numbers:  731221, exp. 9/26/2023; 682221, exp. 11/14/2023;  ff) LMOH50AE, UDI/DI 00191072184443, Lot numbers:  973231, exp. 1/27/2024;  gg) MMCV98V, UDI/DI 00191072155481, Lot numbers:  867221, exp. 5/13/2023; 828221, exp. 6/21/2023; 949231, exp. 2/20/2024;  hh) MMCV98V-03, UDI/DI 00191072155481, Lot numbers:  783221, exp. 8/5/2023;  ii) MMCV98V-04, UDI/DI 00191072155481, Lot numbers:  681221, exp. 11/15/2023;  jj) MMOH64J, UDI/DI none, Lot numbers:  933231, exp. 3/8/2024; 871231, exp. 5/9/2024;  kk) MMPM27E, UDI/DI none, Lot numbers:  935231, exp. 3/6/2024;  ll) MMTR12F, UDI/DI none, Lot numbers:  889231, exp. 4/21/2024;  mm) NCAC96, UDI/DI 00191072016829, Lot numbers:  963231, exp. 8/18/2023; 996231, exp. 6/2/2023; 715221, exp. 6/2/2023; 811221, exp. 6/2/2023; 863221, exp. 5/17/2023;  nn) NCOH11, UDI/DI 00191072160867, Lot numbers:  956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 751221, exp. 4/6/2023; 827221, exp. 6/22/2023; 864221, exp. 5/16/2023;  oo) SAVA91G, UDI/DI none, Lot numbers:  824221, exp. 6/25/2023; 870221, exp. 5/10/2023;  pp) SAVA91H, UDI/DI none, Lot numbers:  790221, exp. 7/29/2023;  qq) SAVA91I, UDI/DI none, Lot numbers:  702221, exp. 10/25/2023; 742221, exp. 9/15/2023;  rr) SAVA91J, UDI/DI none, Lot numbers:  667221, exp. 10/31/2023; 946231, exp. 2/23/2024; 989231, exp. 1/11/2024;  ss) SJOH17I, UDI/DI none, Lot numbers:  696221, exp. 10/31/2023; 747221, exp. 9/10/2023; 778221, exp. 8/10/2023; 817221, exp. 7/2/2023; 863221, exp. 5/17/2023; 988231, exp. 1/12/2024;  tt) SJOH28L, UDI/DI none, Lot numbers:  650221, exp. 12/16/2023; 702221, exp. 10/25/2023; 744221, exp. 9/13/2023; 792221, exp. 7/27/2023; 838221, exp. 6/11/2023; 888221, exp. 4/22/2023; 961231, exp. 2/8/2024; 918231, exp. 3/23/2024;  uu) SJPH34K, UDI/DI none, Lot numbers:  678221, exp. 11/18/2023; 750221, exp. 9/7/2023; 818221, exp. 7/1/2023; 975231, exp. 1/25/2024;  vv) SJVO56A, UDI/DI none, Lot numbers:  763221, exp. 8/25/2023;  ww) SJVO56B, UDI/DI none, Lot numbers:  636221, exp. 12/30/2023; 661221, exp. 12/5/2023; 686221, exp. 11/10/2023; 707221, exp. 10/20/2023; 911231, exp. 3/30/2024; 940231, exp. 3/1/2024; 974231, exp. 1/26/2024;  xx) SVMJ20L, UDI/DI 00191072142405, Lot numbers:  737221, exp. 9/20/2023; 807221, exp. 7/12/2023; 863221, exp. 5/17/2023;  yy) SVMJ20M, UDI/DI 00191072179838, Lot numbers:  903231, exp. 4/7/2024; 955231, exp. 2/14/2024; 681221, exp. 11/15/2023;  zz) SVMN60J, UDI/DI 00191072142412, Lot numbers:  654221, exp. 12/12/2023; 734221, exp. 9/23/2023; 784221, exp. 8/4/2023; 836221, exp. 6/13/2023;  aaa) SVOH38Q, UDI/DI 00191072156488, Lot numbers:  913231, exp. 3/28/2024; 891231, exp. 4/19/2024; 953231, exp. 2/16/2024; 961231, exp. 2/8/2024; 637221, exp. 12/29/2023; 651221, exp. 12/15/2023; 710221, exp. 10/17/2023; 729221, exp. 9/28/2023; 784221, exp. 7/31/2023;  bbb) TNCB10AK, UDI/DI 00191072184948, Lot numbers:  995231, exp. 1/5/2024;  ccc)  UICD62AM, UDI/DI none, Lot numbers:  959231, exp. 2/10/2024; 879231, exp. 5/1/2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}