{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waukegan",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93551",
      "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": "US and EMEA, Japan, Latin America",
      "recall_number": "Z-1047-2024",
      "product_description": "Dover\" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD;  Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC, CSD; Dover\" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 14 FR (4.7 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover\" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M TEMP SENSE FOLEY TRAY, 16 FR (5.3 MM), 5 CC; Dover\" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover\" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 18 FR (6.0 MM), 5 CC, CATH SECURE; Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, CATH SECURE; Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 14 FR (4.7 MM), 5 CC, CATH SECURE; Dover\" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover\" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD",
      "product_quantity": "7800 units",
      "reason_for_recall": "Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.",
      "recall_initiation_date": "20231204",
      "center_classification_date": "20240216",
      "report_date": "20240228",
      "code_info": "P4P14TSD, UDI/DI 20884521066950 (cs), 10884521066953 (ea) Lot Numbers: 2210218264, 2319101064, 2304400564, 2216804964  P4P16XTSD, Lot Numbers: 2204636464, 2304400764, 2214449464, 2303011464,  2319902164, 2305206364, 2313614664, 2322605064  P4P18XTSD, Lot Numbers: 2213739364, 2306628864, 2217920364  P4P14TSD, Lot Numbers: 2210218264, 2319101064, 2304400564, 2216804964  P4P18TS, Lot Numbers: 2219401064, 2210218864  P4P16XTS, Lot Numbers: 2203931464, 2208814964, 2217920264, 2219400964  P4P16TS, Lot Numbers: 2206726264, 2213739064, 2222821064, 2222821164,  2206013564, 2223543364, 2134218364  P4P16ULD, Lot Numbers: 2308007664, 2315604264, 2301703664, 2210218664, 2208814764, 2212321764  P4P14SD, Lot Numbers: 2206725964, 2310807964, 2315604664, 2204636264, 2210901764,  2216500364, 2209524164, 2215824064, 2217919864  P4P18XSD, Lot Numbers: 2231220364, 2310808464, 2204636764  P4P16XSD, Lot Numbers: 2206013664, 2303011364, 2322321564, 2231220164,  2300202364, 2308702164, 2310808264, 2315604164, 2215100464, 2301703764,  2312206864, 2305403964, 2205315564, 2207402864, 2208814864, 2215117964,  2215301864  P4P16SD, Lot Numbers: 2303820764, 2303820864, 2304400664, 2303820664, 2307107964, 2308007864, 2311120164, 2312302264, 2315604364, 2317003864, 2317003964,  2203928364, 2206013464, 2210901964, 2211626964, 2213042864, 2213042964,  2213043064, 2219400764, 2232517664, 2300202164, 2305201964, 2305202064, 2301703464, 2312206664, 2312908564, 2312908664, 2319902064, 2321318164,  2321318264, 2211801264, 2216807664, 2216802864, 2216802764, 2305232164, 2305900264, 2305900364, 2322102964, 2313614864, 2310212764, 2201116464,  2134203264, 2134203364, 2200118864, 2200118964, 2200428164, 2203928464, 2204633964, 2204634064, 2205315364, 2207402764, 2210218564, 2208814664, 2212321664, 2212500164, 2214422064, 2214422164, 2217917064, 2217917164,  2218625764, 2201116564"
    }
  ]
}