{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210186",
      "product_res_number": "Z-0164-2025",
      "event_date_initiated": "2024-09-04",
      "event_date_posted": "2024-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "95415",
      "product_code": "PPB",
      "product_description": "Medline brand medical procedure convenience kits, labeled as:  \na) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; \nb) TRAY FOL LATX UM COUD 16FR  MF, REF DYND150216CS; \nc) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; \nd) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; \ne) TRAY FOL LATX UM COUD 18FR  MF, REF DYND150218CS; \nf) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; \ng) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; \nh) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816; \ni) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS; \nj) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S; \nk) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS; \nl) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S",
      "code_info": "a) REF DYND150200S, UDI/DI 40195327387885 (each), 10195327387884 (case), Lot Numbers:  23LBK182; \nb) REF DYND150216CS, UDI/DI 40195327388059 (each), 10195327388058 (case), Lot Numbers:  23LBK183; \nc) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers:  23LBO854; \nd) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers:  23LBL067; \ne) REF DYND150218CS, UDI/DI 40195327388066 (each), 10195327388065 (case), Lot Numbers:  23LBL068; \nf) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers:  23LBP852; \ng) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers:  23KBK538; \nh) REF DYND150816, UDI/DI 40195327043064 (each), 10195327043063 (case), Lot Numbers:  23KBE406; \ni) REF DYND150816CS, UDI/DI 40195327149919 (each), 10195327149918 (case), Lot Numbers:  23KBU812; \nj) REF DYND150816S, UDI/DI 40195327149711 (each), 10195327149710 (case), Lot Numbers:  24ABA832; \nk) REF DYND150818CS, UDI/DI 40195327149926 (each), 10195327149925 (case), Lot Numbers:  23LBH302; \nl) REF DYND150818S, UDI/DI 40195327149889 (each), 10195327149888 (case), Lot Numbers:  23KBF923",
      "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": "8830 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
      "openfda": {
        "device_name": "Foley Catheter Kit (Excludes Hiv Testing)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5130",
        "device_class": "2",
        "registration_number": [
          "3045816907",
          "1423395",
          "1055236",
          "3007329020",
          "3005012805",
          "3009888344",
          "2320762",
          "1054241",
          "3036112794",
          "3004111573",
          "1423537",
          "1643817",
          "1921846",
          "3045816902",
          "1928237",
          "3006542380",
          "3015173212",
          "1061124",
          "3004122598",
          "3017059795",
          "3005669815",
          "3005034064",
          "9616088",
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          "3005595283"
        ],
        "fei_number": [
          "3045816907",
          "3007329020",
          "3005012805",
          "3009888344",
          "3036112794",
          "3004111573",
          "1643817",
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          "3002806934",
          "1921846",
          "3000717925",
          "3045816902",
          "1928237",
          "3006542380",
          "3015173212",
          "3004122598",
          "1000512168",
          "3017059795",
          "3001236905",
          "3005669815",
          "3005034064",
          "1000112877",
          "3002902735",
          "1000112968",
          "3005595283"
        ]
      }
    }
  ]
}