{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "211372",
      "product_res_number": "Z-0778-2025",
      "event_date_initiated": "2024-11-21",
      "event_date_posted": "2024-12-30",
      "recall_status": "Open, Classified",
      "res_event_number": "95852",
      "product_code": "OEZ",
      "product_description": "Medline custom medical procedure kits labeled as:  \n1) OPEN HEART CDS-LF, REFCDS840451M; \n2) NEURO PACK, REFDYNJ41516M; \n3) RFD- AAA PACK, REFDYNJ54242B; \n4) OPEN HEART A&B, REFDYNJ901203C; \n5) OPEN HEART A&B, REFDYNJ901203D; \n6) ACDF-LF, REFDYNJ906681B; \n7) ACDF-LF, REFDYNJ906681C.",
      "code_info": "1) REF CDS840451M, UDI/DI  10195327417574 (EA) 40195327417575 (CS), Lot Numbers:  24BLA736;  \n\n2) REF DYNJ41516M, UDI/DI  10193489202564 (EA) 40193489202565 (CS), Lot Numbers:  19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171; \n\n3) REF DYNJ54242B, UDI/DI  10195327167097 (EA) 40195327167098 (CS), Lot Numbers: 23GBO400;  \n\n4) REF DYNJ901203C, UDI/DI  10889942572526 (EA) 40889942572527 (CS), Lot numbers:  19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734; \n\n5) REF DYNJ901203D, UDI/DI  10193489947526 (EA) 40193489947527 (CS), Lot Numbers: 21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830;  \n\n6) REF DYNJ906681B, UDI/DI  10195327106881 (EA) 40195327106882 (CS), Lot Numbers: 22FBC663, 22OBM278;  \n\n7) REF DYNJ906681C, UDI/DI  10195327173838 (EA) 40195327173839 (CS) , Lot Numbers:  22IBR002, 22JBV571, 22JBW937, 22KBB923, 22LBK562, 23ABC493, 23GBR644, 23IBP138, 23IBV201, 23JBK264, 23LBE604, 23LBS964, 24CBP708, 24EBA703, 24GBL458.",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email.  The notice explained the issue, potential risk to health, and requested that the affected product be quarantined.  Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.",
      "product_quantity": "2344 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of UAE, and Canada.",
      "openfda": {
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}