{
  "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-1048-2024",
      "product_description": "Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover\" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover\" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover\" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 16FR (5.3 MM), 5CC; Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover\" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 18FR (6.0 MM), 5CC; Dover\" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE",
      "product_quantity": "195600 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": "a) P4P16CSDK, UDI/DI 20884521174068 (cs), 10884521174061 (ea), Lot Numbers:  2134218264, 2231213064, 2231213164, 2231901164, 2231901264, 2303822464, 2303007064, 2307110664, 2310808164, 2315609464, 2319100364, 2319213064, 2203300964, 2210218464, 2211031564, 2213045564, 2214449364, 2215824164, 2216500464, 2217920064, 2219400664, 2300202064, 2304400364, 2304400464, 2301703364, 2303006964, 2308700564, 2309041264, 2312206464, 2321324164, 2322006864, 2211626864, 2305206264, 2322102764, 2206726164, 2216805064, 2313615064, 2313614964, 2312908364, 2309041264, 2201151164, 2201201664, 2202401464, 2200603564, 2205315264, 2209524264, 2213738964, 2215117864;    b) P4P18CSDK, UDI/DI 20884521174075 (cs), 10884521174078(ea), Lot Numbers: 2231213564, 2308004464, 2319100564, 2215824364, 2232517864, 2312206964, 2134218564, 2203931664"
    }
  ]
}