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  "name": "Custom procedural convenience kits and trays, gastroenterological & urological, labeled as:    a)\tLAP KIDNEY MODULE, kit number AGKD50L;   b)\tROBOTIC PROSTATE PACK - 264852, kit number ANPR34S;   c)\tLAP CHOLE - 213388, kit number BFLC02AD;   d)\tGENERAL LAPAROSCOPY PACK, kit number GUGE09I;   e)\tLAP CHOLE PACK, kit number HNLC80I;   f)\tLap Chole Ovarian Appy, kit number JSLC06I;   g)\tLAP CHOLE, ST LUKES, kit number LMLP08Z;   h)\tROBOTIC PACK - 242561, kit number MHRB88AJ;   i)\tKIT, GENERAL LAPAROSCOPY, kit number MMLP40F;   j)\tKIT, MAJOR LAPAROTOMY, kit number MMML26F;   k)\tLAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K;   l)\tGENERAL LAPAROSCOPY SAH, kit number SAGL57H;   m)\tROBOTIC PACK SAH, kit number SARB30K;   n)\tROBOTIC PACK SAH, kit number SARB30L;   o)\tROBOTIC PACK SAH, kit number SARB30M;   p)\tLAP CHOLE PACK, kit number SMLC53;   q)\tROBOTICS PACK, kit number SNRP85D;   r)\tROBOTIC PACK, kit number SSRO22C;   s)\tROBOTIC PACK, kit number SSRO22D;   t)\tTPK DAVINCI PROSTATE SYSTEM, kit number TPDV16;   u)\tASC LAP CHOLE PACK (PS 42279), kit number UICH53Y;   v)\tGENERAL LAPAROSCOPIC PACK, kit number WVGL60E",
  "description": "FDA recall Z-0822-2024 — American Contract Systems, Inc. is recalling Custom procedural convenience kits and trays, gastroenterological & urological, labeled as:    a)\tLAP KIDNEY MODULE, kit number AGKD50L;   b)\tROBOTIC PROSTATE PACK - 264852, kit number ANPR34S;   c)\tLAP CHOLE - 213388, kit number BFLC02AD;   d)\tGENERAL LAPAROSCOPY PACK, kit number GUGE09I;   e)\tLAP CHOLE PACK, kit number HNLC80I;   f)\tLap Chole Ovarian Appy, kit number JSLC06I;   g)\tLAP CHOLE, ST LUKES, kit number LMLP08Z;   h)\tROBOTIC PACK - 242561, kit number MHRB88AJ;   i)\tKIT, GENERAL LAPAROSCOPY, kit number MMLP40F;   j)\tKIT, MAJOR LAPAROTOMY, kit number MMML26F;   k)\tLAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K;   l)\tGENERAL LAPAROSCOPY SAH, kit number SAGL57H;   m)\tROBOTIC PACK SAH, kit number SARB30K;   n)\tROBOTIC PACK SAH, kit number SARB30L;   o)\tROBOTIC PACK SAH, kit number SARB30M;   p)\tLAP CHOLE PACK, kit number SMLC53;   q)\tROBOTICS PACK, kit number SNRP85D;   r)\tROBOTIC PACK, kit number SSRO22C;   s)\tROBOTIC PACK, kit number SSRO22D;   t)\tTPK DAVINCI PROSTATE SYSTEM, kit number TPDV16;   u)\tASC LAP CHOLE PACK (PS 42279), kit number UICH53Y;   v)\tGENERAL LAPAROSCOPIC PACK, kit number WVGL60E (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "Custom procedural convenience kits and trays, gastroenterological & urological, labeled as:    a)\tLAP KIDNEY MODULE, kit number AGKD50L;   b)\tROBOTIC PROSTATE PACK - 264852, kit number ANPR34S;   c)\tLAP CHOLE - 213388, kit number BFLC02AD;   d)\tGENERAL LAPAROSCOPY PACK, kit number GUGE09I;   e)\tLAP CHOLE PACK, kit number HNLC80I;   f)\tLap Chole Ovarian Appy, kit number JSLC06I;   g)\tLAP CHOLE, ST LUKES, kit number LMLP08Z;   h)\tROBOTIC PACK - 242561, kit number MHRB88AJ;   i)\tKIT, GENERAL LAPAROSCOPY, kit number MMLP40F;   j)\tKIT, MAJOR LAPAROTOMY, kit number MMML26F;   k)\tLAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K;   l)\tGENERAL LAPAROSCOPY SAH, kit number SAGL57H;   m)\tROBOTIC PACK SAH, kit number SARB30K;   n)\tROBOTIC PACK SAH, kit number SARB30L;   o)\tROBOTIC PACK SAH, kit number SARB30M;   p)\tLAP CHOLE PACK, kit number SMLC53;   q)\tROBOTICS PACK, kit number SNRP85D;   r)\tROBOTIC PACK, kit number SSRO22C;   s)\tROBOTIC PACK, kit number SSRO22D;   t)\tTPK DAVINCI PROSTATE SYSTEM, kit number TPDV16;   u)\tASC LAP CHOLE PACK (PS 42279), kit number UICH53Y;   v)\tGENERAL LAPAROSCOPIC PACK, kit number WVGL60E",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0822-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0822-2024: American Contract Systems, Inc. is recalling Custom procedural convenience kits and trays, gastroenterological & urological, labeled as:    a)\tLAP KIDNEY MODULE, kit number AGKD50L;   b)\tROBOTIC PROSTATE PACK - 264852, kit number ANPR34S;   c)\tLAP CHOLE - 213388, kit number BFLC02AD;   d)\tGENERAL LAPAROSCOPY PACK, kit number GUGE09I;   e)\tLAP CHOLE PACK, kit number HNLC80I;   f)\tLap Chole Ovarian Appy, kit number JSLC06I;   g)\tLAP CHOLE, ST LUKES, kit number LMLP08Z;   h)\tROBOTIC PACK - 242561, kit number MHRB88AJ;   i)\tKIT, GENERAL LAPAROSCOPY, kit number MMLP40F;   j)\tKIT, MAJOR LAPAROTOMY, kit number MMML26F;   k)\tLAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K;   l)\tGENERAL LAPAROSCOPY SAH, kit number SAGL57H;   m)\tROBOTIC PACK SAH, kit number SARB30K;   n)\tROBOTIC PACK SAH, kit number SARB30L;   o)\tROBOTIC PACK SAH, kit number SARB30M;   p)\tLAP CHOLE PACK, kit number SMLC53;   q)\tROBOTICS PACK, kit number SNRP85D;   r)\tROBOTIC PACK, kit number SSRO22C;   s)\tROBOTIC PACK, kit number SSRO22D;   t)\tTPK DAVINCI PROSTATE SYSTEM, kit number TPDV16;   u)\tASC LAP CHOLE PACK (PS 42279), kit number UICH53Y;   v)\tGENERAL LAPAROSCOPIC PACK, kit number WVGL60E",
      "text": "The FDA logged enforcement record Z-0822-2024: American Contract Systems, Inc. is voluntarily recalling Custom procedural convenience kits and trays, gastroenterological & urological, labeled as:    a)\tLAP KIDNEY MODULE, kit number AGKD50L;   b)\tROBOTIC PROSTATE PACK - 264852, kit number ANPR34S;   c)\tLAP CHOLE - 213388, kit number BFLC02AD;   d)\tGENERAL LAPAROSCOPY PACK, kit number GUGE09I;   e)\tLAP CHOLE PACK, kit number HNLC80I;   f)\tLap Chole Ovarian Appy, kit number JSLC06I;   g)\tLAP CHOLE, ST LUKES, kit number LMLP08Z;   h)\tROBOTIC PACK - 242561, kit number MHRB88AJ;   i)\tKIT, GENERAL LAPAROSCOPY, kit number MMLP40F;   j)\tKIT, MAJOR LAPAROTOMY, kit number MMML26F;   k)\tLAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K;   l)\tGENERAL LAPAROSCOPY SAH, kit number SAGL57H;   m)\tROBOTIC PACK SAH, kit number SARB30K;   n)\tROBOTIC PACK SAH, kit number SARB30L;   o)\tROBOTIC PACK SAH, kit number SARB30M;   p)\tLAP CHOLE PACK, kit number SMLC53;   q)\tROBOTICS PACK, kit number SNRP85D;   r)\tROBOTIC PACK, kit number SSRO22C;   s)\tROBOTIC PACK, kit number SSRO22D;   t)\tTPK DAVINCI PROSTATE SYSTEM, kit number TPDV16;   u)\tASC LAP CHOLE PACK (PS 42279), kit number UICH53Y;   v)\tGENERAL LAPAROSCOPIC PACK, kit number WVGL60E — 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) AGKD50L, UDI/DI 00191072141156, Lot Numbers:   905231, exp. 4/5/2024; 638221, exp. 12/28/2023; 689221, exp. 5/21/2023;  b) ANPR34S, UDI/DI 00191072171351, Lot Numbers:  721221, exp. 10/6/2023; 879231, exp. 5/1/2024; 896231, exp. 4/14/2024; 927231, exp. 3/14/2024; 956231, exp. 2/13/2024; 645221, exp. 12/21/2023;  c) BFLC02AD, UDI/DI 00191072169075, Lot Numbers:  654221, exp. 12/12/2023; 647221, exp. 12/19/2023; 987231, exp. 1/13/2024; UDI/DI 00191072188830, Lot Numbers:  946231, exp. 2/23/2024; 896231, exp. 4/14/2024;  d) GUGE09I, UDI/DI none, Lot Numbers:  768221, exp. 8/20/2023;  e) HNLC80I, UDI/DI 00191072146267, Lot Numbers: 797221, exp. 7/22/2023; 679221, exp. 11/17/2023; 995231, exp. 1/25/2024; 911231, exp. 3/30/2024;   f) JSLC06I, UDI/DI 00191072126061, Lot Numbers:  839221, exp. 6/10/2023; 766221, exp. 8/22/2023;  g) LMLP08Z, UDI/DI none, Lot Numbers:  661221, exp. 12/5/2023; 987231, exp. 1/13/2024; 942231, exp. 2/27/2024; 893231, exp. 4/17/2024;  h) MHRB88AJ, UDI/DI none, Lot Numbers:  735221, exp. 9/22/2023; 710221, exp. 10/17/2023; 997231, exp. 1/3/2024; 959231, exp. 2/10/2024; 904231, exp. 4/6/2024;  i) MMLP40F, UDI/DI none, Lot Numbers:  933231, exp. 3/8/2024; 879231, exp. 5/1/2024;  j) MMML26F, UDI/DI none, Lot Numbers:  989231, exp. 1/11/2024; 896231, exp. 4/14/2024;  k) OWLC07K, UDI/DI none, Lot Numbers:  682221, exp. 11/14/2023; 646221, exp. 12/20/2023; 982231, exp. 1/18/2024; 928231, exp. 3/13/2024;  l) SAGL57H, UDI/DI none, Lot Numbers:  687221, exp. 11/9/2023; 790221, exp. 7/29/2023;  m) SARB30K, UDI/DI none, Lot Numbers:  845221, exp. 6/4/2023; 888221, exp. 4/22/2023;  n) SARB30L, UDI/DI none, Lot Numbers:  752221, exp. 9/5/2023;  o) SARB30M, UDI/DI none, Lot Numbers:  658221, exp. 12/8/2023; 700221, exp. 10/27/2023; 792221, exp. 7/27/2023; 949231, exp. 2/20/2024; 983231, exp. 1/17/2024;  p) SMLC53, UDI/DI 00191072188465, Lot Numbers:  969231, exp. 1/31/2024;  q) SNRP85D, UDI/DI none, Lot Numbers:  666221, exp. 11/30/2023; 720221, exp. 10/7/2023; 793221, exp. 7/26/2023; 853221, exp. 5/27/2023; 965231, exp. 2/4/2024;  r) SSRO22C, UDI/DI none, Lot Numbers:  891221, exp. 04/19/2023;  s) SSRO22D, UDI/DI none, Lot Numbers:  660221, exp. 5/31/2023;  698221, exp. 10/29/2023;  756221, exp. 9/1/2023;  804221, exp. 7/15/2023;  840221, exp. 6/9/2023;  933231, exp. 8/31/2023;  987231, exp. 1/13/2024;   t) TPDV16, UDI/DI 00191072128904, Lot Numbers:  856221, exp. 5/24/2023;  744221, exp. 9/13/2023;  675221, exp. 11/21/2023;  932231, exp. 3/9/2024;   u) UICH53Y, UDI/DI none, Lot Numbers:  897231, exp. 4/13/2024; 882231, exp. 4/28/2024;  v) WVGL60E, UDI/DI 00191072144034, Lot Numbers:  766221, exp. 8/22/2023; 694221, exp. 11/2/2023; 952231, exp. 2/17/2024;. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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        "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-0822-2024&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-0822-2024&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-0822-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0822-2024 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
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0822-2024&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-0822-2024&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-0822-2024/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
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
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            "Value": "Z-0822-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "American Contract Systems, Inc.",
            "Status": "recorded"
          }
        },
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          "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"
          }
        },
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) AGKD50L, UDI/DI 00191072141156, Lot Numbers:   905231, exp. 4/5/2024; 638221, exp. 12/28/2023; 689221, exp. 5/21/2023;  b) ANPR34S, UDI/DI 00191072171351, Lot Numbers:  721221, exp. 10/6/2023; 879231, exp. 5/1/2024; 896231, exp. 4/14/2024; 927231, exp. 3/14/2024; 956231, exp. 2/13/2024; 645221, exp. 12/21/2023;  c) BFLC02AD, UDI/DI 00191072169075, Lot Numbers:  654221, exp. 12/12/2023; 647221, exp. 12/19/2023; 987231, exp. 1/13/2024; UDI/DI 00191072188830, Lot Numbers:  946231, exp. 2/23/2024; 896231, exp. 4/14/2024;  d) GUGE09I, UDI/DI none, Lot Numbers:  768221, exp. 8/20/2023;  e) HNLC80I, UDI/DI 00191072146267, Lot Numbers: 797221, exp. 7/22/2023; 679221, exp. 11/17/2023; 995231, exp. 1/25/2024; 911231, exp. 3/30/2024;   f) JSLC06I, UDI/DI 00191072126061, Lot Numbers:  839221, exp. 6/10/2023; 766221, exp. 8/22/2023;  g) LMLP08Z, UDI/DI none, Lot Numbers:  661221, exp. 12/5/2023; 987231, exp. 1/13/2024; 942231, exp. 2/27/2024; 893231, exp. 4/17/2024;  h) MHRB88AJ, UDI/DI none, Lot Numbers:  735221, exp. 9/22/2023; 710221, exp. 10/17/2023; 997231, exp. 1/3/2024; 959231, exp. 2/10/2024; 904231, exp. 4/6/2024;  i) MMLP40F, UDI/DI none, Lot Numbers:  933231, exp. 3/8/2024; 879231, exp. 5/1/2024;  j) MMML26F, UDI/DI none, Lot Numbers:  989231, exp. 1/11/2024; 896231, exp. 4/14/2024;  k) OWLC07K, UDI/DI none, Lot Numbers:  682221, exp. 11/14/2023; 646221, exp. 12/20/2023; 982231, exp. 1/18/2024; 928231, exp. 3/13/2024;  l) SAGL57H, UDI/DI none, Lot Numbers:  687221, exp. 11/9/2023; 790221, exp. 7/29/2023;  m) SARB30K, UDI/DI none, Lot Numbers:  845221, exp. 6/4/2023; 888221, exp. 4/22/2023;  n) SARB30L, UDI/DI none, Lot Numbers:  752221, exp. 9/5/2023;  o) SARB30M, UDI/DI none, Lot Numbers:  658221, exp. 12/8/2023; 700221, exp. 10/27/2023; 792221, exp. 7/27/2023; 949231, exp. 2/20/2024; 983231, exp. 1/17/2024;  p) SMLC53, UDI/DI 00191072188465, Lot Numbers:  969231, exp. 1/31/2024;  q) SNRP85D, UDI/DI none, Lot Numbers:  666221, exp. 11/30/2023; 720221, exp. 10/7/2023; 793221, exp. 7/26/2023; 853221, exp. 5/27/2023; 965231, exp. 2/4/2024;  r) SSRO22C, UDI/DI none, Lot Numbers:  891221, exp. 04/19/2023;  s) SSRO22D, UDI/DI none, Lot Numbers:  660221, exp. 5/31/2023;  698221, exp. 10/29/2023;  756221, exp. 9/1/2023;  804221, exp. 7/15/2023;  840221, exp. 6/9/2023;  933231, exp. 8/31/2023;  987231, exp. 1/13/2024;   t) TPDV16, UDI/DI 00191072128904, Lot Numbers:  856221, exp. 5/24/2023;  744221, exp. 9/13/2023;  675221, exp. 11/21/2023;  932231, exp. 3/9/2024;   u) UICH53Y, UDI/DI none, Lot Numbers:  897231, exp. 4/13/2024; 882231, exp. 4/28/2024;  v) WVGL60E, UDI/DI 00191072144034, Lot Numbers:  766221, exp. 8/22/2023; 694221, exp. 11/2/2023; 952231, exp. 2/17/2024;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}