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  "name": "Procedure packs:    (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;  (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular.  (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile;  (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile;  (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile;  (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile;  (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile;  (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile;  (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile;  (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile;  (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile;  (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile;  (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile;  (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile;  (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile;  (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile;  (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile;  (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile;  (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile;  (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile;  (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile;  (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile;  (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile;  (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile;  (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile;  (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile  (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile;  (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile;  (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile;  (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile;  (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile;   (32) Presource EVAR, Cat. SCV30EVTHE, Trillium  Health Centre, Sterile;  (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile;  (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.",
  "description": "FDA recall Z-0084-2024 — Cardinal Health 200, LLC is recalling Procedure packs:    (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;  (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular.  (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile;  (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile;  (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile;  (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile;  (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile;  (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile;  (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile;  (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile;  (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile;  (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile;  (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile;  (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile;  (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile;  (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile;  (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile;  (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile;  (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile;  (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile;  (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile;  (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile;  (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile;  (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile;  (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile;  (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile  (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile;  (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile;  (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile;  (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile;  (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile;   (32) Presource EVAR, Cat. SCV30EVTHE, Trillium  Health Centre, Sterile;  (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile;  (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile. (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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    "@type": "schema:MedicalDevice",
    "name": "Procedure packs:    (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;  (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular.  (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile;  (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile;  (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile;  (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile;  (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile;  (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile;  (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile;  (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile;  (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile;  (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile;  (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile;  (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile;  (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile;  (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile;  (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile;  (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile;  (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile;  (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile;  (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile;  (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile;  (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile;  (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile;  (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile;  (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile  (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile;  (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile;  (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile;  (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile;  (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile;   (32) Presource EVAR, Cat. SCV30EVTHE, Trillium  Health Centre, Sterile;  (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile;  (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0084-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0084-2024: Cardinal Health 200, LLC is recalling Procedure packs:    (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;  (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular.  (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile;  (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile;  (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile;  (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile;  (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile;  (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile;  (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile;  (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile;  (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile;  (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile;  (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile;  (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile;  (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile;  (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile;  (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile;  (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile;  (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile;  (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile;  (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile;  (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile;  (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile;  (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile;  (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile;  (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile  (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile;  (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile;  (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile;  (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile;  (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile;   (32) Presource EVAR, Cat. SCV30EVTHE, Trillium  Health Centre, Sterile;  (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile;  (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.",
      "text": "The FDA logged enforcement record Z-0084-2024: Cardinal Health 200, LLC is voluntarily recalling Procedure packs:    (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;  (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular.  (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile;  (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile;  (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile;  (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile;  (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile;  (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile;  (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile;  (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile;  (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile;  (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile;  (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile;  (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile;  (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile;  (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile;  (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile;  (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile;  (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile;  (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile;  (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile;  (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile;  (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile;  (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile;  (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile;  (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile  (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile;  (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile;  (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile;  (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile;  (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile;   (32) Presource EVAR, Cat. SCV30EVTHE, Trillium  Health Centre, Sterile;  (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile;  (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile. — reason: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-16. Affected lots/codes: (1) Cat. PC71EXOU7 - Lot #916915, Exp. 5/1/2024, UDI-DI 10195594873332; (2) Cat. PVOCMVBLC - Lot #922978, Exp. 10/1/2024; and Lot #922978, Exp. 7/1/2024, UDI-DI 10195594763183; (3) Cat. PVRMMVAOH7 - Lot #923996, Exp. 1/1/2024, UDI-DI 10195594892777; (4) Cat. PV30VPUHA - Lot #898892, Exp. 2/1/2024, UDI-DI 10195594485894; (5) Cat. SANOCCPDM2 - Lot #920122, Exp. 6/1/2025, UDI-DI 10195594882273; (6) Cat. SAN1FPMULM - Lot #929016, Exp. 6/1/2024, UDI-DI 10195594712938; (7) Cat. SAN11OADMM - Lot #985859, Exp. 11/1/2025, UDI-DI 10195594553562; (8) Cat. SAN13DILCO - Lot #936019, Exp. 8/1/2024, UDI-DI 10888439914443; (9) Cat. SAN13DILC6 - Lot #22275, Exp. 5/1/2024, UDI-DI 10197106209561; (10) Cat. SAN21AO62F - Lot #901120, Exp. 8/1/2024, UDI-DI 10888439936100; (11) Cat. SAN21APJCD - Lot #922242, Exp. 8/1/2024, UDI-DI 10195594574918; (12) Cat. SAN21IP62I - Lot #917437, Exp. 6/1/2024, UDI-DI 10888439936018; (13) Cat. SAN23CMCW5 - Lot #919954, Exp. 7/1/2024, UDI-DI 10195594885915; (14) Cat. SAN29PCCCL - Lot #999073, Exp. 6/1/2027, UDI-DI 10888439917291; (15) Cat. SAN3BPDKOC - Lot #942109, Exp. 1/1/2024, UDI-DI 10888439964530; (16) Cat. SAN3BPDK12 - Lot #914221, Exp. 1/1/2024, UDI-DI 10195594863579; (17) Cat. SAN30ANTHD - Lot #16600, Exp. 7/1/2025, UDI-DI 10888439973334; (18) Cat. SAN30PPVGA - Lot #922151, Exp. 5/1/2025, UDI-DI 10195594119409; (19) Cat. SAN32IPJWA - Lot #986373, Exp. 4/1/2024, UDI-DI 10888439903881; (20) Cat. SAN33HCSFI - Lot #918244, Exp. 10/1/2024, UDI-DI 10195594302375; (21) Cat. SAN33PMDWI - Lot #973944, Exp. 9/1/2027, UDI-DI 10888439900880; (22) Cat. SAN53OPVMG - Lot #916151, Exp. 7/1/2024, UDI-DI 10195594764401; (23) Cat. SAN55PMMMK - Lot #940130, Exp. 4/1/2024, UDI-DI 10195594395247; (24) Cat. SAN55PMMM9 - Lot #920265, Exp. 9/1/2024, UDI-DI 10195594892173; (25) Cat. SAN57PM80G - Lot #918511, Exp. 4/1/2025, UDI-DI 10195594714451; (26) Cat. SAN69ENKBK - Lot #940361, Exp. 8/1/2025, UDI-DI 10888439549881; (27) Cat. SCVOCVACMI - Lot #924218, Exp. 12/1/2024, UDI-DI 10195594696924; (28) Cat. SCVW1VAHFL - Lot #945247, Exp. 8/1/2025, UDI-DI 10888439912173; (29) Cat. SCV11AVDMF - Lot #17725, Exp. 6/1/2025, UDI-DI 10197106013328;s (30) Cat. SCV11AVD13 - Lot #59718, Exp. 12/1/2025, UDI-DI 10197106306543; (31) Cat. SCV11TBTJH - Lot #940443, Exp. 2/1/2024, UDI-DI 10888439899078; (32) Cat. SCV30EVTHE - Lot #38772, Exp. 1/1/2025, UDI-DI 10888439973235; (33) Cat. SCV30PMRGA - Lot #9591, Exp. 10/1/2027, UDI-DI 10887488561110; and  (34) Cat. SOT30PCHSC  - Lot #54914, Exp. 3/1/2024, UDI-DI 10195594626402.. 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-0084-2024&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-0084-2024&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-0084-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0084-2024 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-0084-2024&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-0084-2024&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-0084-2024/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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0084-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0084-2024",
            "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": "Cardinal Health 200, LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-08-16",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "(1) Cat. PC71EXOU7 - Lot #916915, Exp. 5/1/2024, UDI-DI 10195594873332; (2) Cat. PVOCMVBLC - Lot #922978, Exp. 10/1/2024; and Lot #922978, Exp. 7/1/2024, UDI-DI 10195594763183; (3) Cat. PVRMMVAOH7 - Lot #923996, Exp. 1/1/2024, UDI-DI 10195594892777; (4) Cat. PV30VPUHA - Lot #898892, Exp. 2/1/2024, UDI-DI 10195594485894; (5) Cat. SANOCCPDM2 - Lot #920122, Exp. 6/1/2025, UDI-DI 10195594882273; (6) Cat. SAN1FPMULM - Lot #929016, Exp. 6/1/2024, UDI-DI 10195594712938; (7) Cat. SAN11OADMM - Lot #985859, Exp. 11/1/2025, UDI-DI 10195594553562; (8) Cat. SAN13DILCO - Lot #936019, Exp. 8/1/2024, UDI-DI 10888439914443; (9) Cat. SAN13DILC6 - Lot #22275, Exp. 5/1/2024, UDI-DI 10197106209561; (10) Cat. SAN21AO62F - Lot #901120, Exp. 8/1/2024, UDI-DI 10888439936100; (11) Cat. SAN21APJCD - Lot #922242, Exp. 8/1/2024, UDI-DI 10195594574918; (12) Cat. SAN21IP62I - Lot #917437, Exp. 6/1/2024, UDI-DI 10888439936018; (13) Cat. SAN23CMCW5 - Lot #919954, Exp. 7/1/2024, UDI-DI 10195594885915; (14) Cat. SAN29PCCCL - Lot #999073, Exp. 6/1/2027, UDI-DI 10888439917291; (15) Cat. SAN3BPDKOC - Lot #942109, Exp. 1/1/2024, UDI-DI 10888439964530; (16) Cat. SAN3BPDK12 - Lot #914221, Exp. 1/1/2024, UDI-DI 10195594863579; (17) Cat. SAN30ANTHD - Lot #16600, Exp. 7/1/2025, UDI-DI 10888439973334; (18) Cat. SAN30PPVGA - Lot #922151, Exp. 5/1/2025, UDI-DI 10195594119409; (19) Cat. SAN32IPJWA - Lot #986373, Exp. 4/1/2024, UDI-DI 10888439903881; (20) Cat. SAN33HCSFI - Lot #918244, Exp. 10/1/2024, UDI-DI 10195594302375; (21) Cat. SAN33PMDWI - Lot #973944, Exp. 9/1/2027, UDI-DI 10888439900880; (22) Cat. SAN53OPVMG - Lot #916151, Exp. 7/1/2024, UDI-DI 10195594764401; (23) Cat. SAN55PMMMK - Lot #940130, Exp. 4/1/2024, UDI-DI 10195594395247; (24) Cat. SAN55PMMM9 - Lot #920265, Exp. 9/1/2024, UDI-DI 10195594892173; (25) Cat. SAN57PM80G - Lot #918511, Exp. 4/1/2025, UDI-DI 10195594714451; (26) Cat. SAN69ENKBK - Lot #940361, Exp. 8/1/2025, UDI-DI 10888439549881; (27) Cat. SCVOCVACMI - Lot #924218, Exp. 12/1/2024, UDI-DI 10195594696924; (28) Cat. SCVW1VAHFL - Lot #945247, Exp. 8/1/2025, UDI-DI 10888439912173; (29) Cat. SCV11AVDMF - Lot #17725, Exp. 6/1/2025, UDI-DI 10197106013328;s (30) Cat. SCV11AVD13 - Lot #59718, Exp. 12/1/2025, UDI-DI 10197106306543; (31) Cat. SCV11TBTJH - Lot #940443, Exp. 2/1/2024, UDI-DI 10888439899078; (32) Cat. SCV30EVTHE - Lot #38772, Exp. 1/1/2025, UDI-DI 10888439973235; (33) Cat. SCV30PMRGA - Lot #9591, Exp. 10/1/2027, UDI-DI 10887488561110; and  (34) Cat. SOT30PCHSC  - Lot #54914, Exp. 3/1/2024, UDI-DI 10195594626402.",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV.  There was government distribution and no military distribution. The country of Canada.",
            "Status": "recorded"
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}