{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210199",
      "product_res_number": "Z-0177-2025",
      "event_date_initiated": "2024-09-04",
      "event_date_posted": "2024-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "95415",
      "product_code": "OKV",
      "product_description": "Medline brand medical procedure convenience kits, labeled as:  \na) OB PACK-LF, REF DYNJ0912449M; \nb) OB PACK, REF DYNJ17309G; \nc) OB PK, REF DYNJ34268D; \nd) OB DELIVERY PACK, REF DYNJ34274B; \ne) OB DELIVERY PACK, REF DYNJ34274B; \nf) D AND C PACK, REF DYNJ39668I; \ng) OB PACK, REF DYNJ42884; \nh) RFT D & C PACK, REF DYNJ50851; \ni) KIT OB, REF DYNJ906623; \nj) D AND C, REF DYNJ907957A; \nk) CHS OB PACK III, REF DYNJCH907",
      "code_info": "a) REF DYNJ0912449M, UDI/DI 40889942437536 (each), 10889942437535 (case), Lot Numbers:  23LBP185; \nb) REF DYNJ17309G, UDI/DI 40193489277181 (each), 10193489277180 (case), Lot Numbers:  24ABB399; \nc) REF DYNJ34268D, UDI/DI 40193489821421 (each), 10193489821420 (case), Lot Numbers:  23LBM844; \nd) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers:  23LBS099; \ne) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers:  23KBB869; \nf) REF DYNJ39668I, UDI/DI 40195327456284 (each), 10195327456283 (case), Lot Numbers:  23LBM868; \ng) REF DYNJ42884, UDI/DI 40888277011077 (each), 10888277011076 (case), Lot Numbers:  23KBB574; \nh) REF DYNJ50851, UDI/DI 40889942029014 (each), 10889942029013 (case), Lot Numbers:  23LBL975; \ni) REF DYNJ906623, UDI/DI 40193489794695 (each), 10193489794694 (case), Lot Numbers:  24ABE587; \nj) REF DYNJ907957A, UDI/DI 40195327189854 (each), 10195327189853 (case), Lot Numbers:  24BBA954; \nk) REF DYNJCH907, UDI/DI 40193489391979 (each), 10193489391978 (case), Lot Numbers:  24ABC904",
      "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": "Karin Johnson\n866-359-1704",
      "reason_for_recall": "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS.  The notice explained the issue, hazard, and requested the destruction of the affected product.  Distributors were directed to notify their consignees.",
      "product_quantity": "1506 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
      "openfda": {
        "device_name": "Obstetrical Kit",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4520",
        "device_class": "2",
        "registration_number": [
          "1423537",
          "1423395",
          "3002807314",
          "3009888344",
          "3010155661",
          "3005012805",
          "1047429",
          "3006410968",
          "1061124",
          "2433012",
          "1643817",
          "3011144486",
          "3015173212",
          "1030451",
          "3004122598",
          "2029015",
          "3009337401",
          "3045816907",
          "1123137",
          "3005595283",
          "3035642068",
          "3045816902",
          "1928237",
          "9616088",
          "1721432",
          "3004111573",
          "3007329020"
        ],
        "fei_number": [
          "3002807314",
          "3009888344",
          "3010155661",
          "3005012805",
          "1000160458",
          "3000717925",
          "3002902735",
          "1047429",
          "3001236905",
          "1000123180",
          "3006410968",
          "2433012",
          "1643817",
          "3011144486",
          "3015173212",
          "1030451",
          "3004122598",
          "1000512168",
          "3009337401",
          "3045816907",
          "3005595283",
          "3035642068",
          "3045816902",
          "1928237",
          "1721432",
          "3004111573",
          "3007329020"
        ]
      }
    }
  ]
}