{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waukegan",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92875",
      "recalling_firm": "Cardinal Health 200, LLC",
      "address_1": "3651 Birchwood Dr",
      "address_2": "N/A",
      "postal_code": "60085-8337",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-0084-2024",
      "product_description": "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.",
      "product_quantity": "13,351 total packs",
      "reason_for_recall": "Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).",
      "recall_initiation_date": "20230816",
      "center_classification_date": "20231010",
      "report_date": "20231018",
      "code_info": "(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."
    }
  ]
}