{
  "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-1045-2024",
      "product_description": "Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover\" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover\" UNIVERSAL TRAY, 1200 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover\" 100% SILICONE FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover\" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover\" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover\" 100% SILICONE FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover\" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover\" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover\" URINE METER ADD-A-FOLEY TRAY, 400 ML, NEEDLE SAMPLING, DRAIN SPOUT, PREP TRAY; Dover\" SILICONE ELASTOMER COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover\" 100% SILICONE FOLEY CATHETER KIT, 5 CC, 2-WAY, 16 FR (5.3 MM), LUBE, STRL WATER, 10CC SYRINGE; Dover\" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover\" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover\" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE",
      "product_quantity": "17640 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) 8887600776, UDI/DI 30884521003389 (cs), 10884521003385 (ea), Lot Numbers:  2301032164, 2206016464, 2210904964, 2218622964, 2225305364, 2305232064, 2217924364.   REF 6256, Lot Number: 2209525764 REF 6175, Lot Numbers: 2205319864, 2205328564 REF 2018, Lot Numbers: 2205334664  REF 76020, Lot Numbers: 2209408564, 2210208264, 2211007864, 2211610264, 2215109464, 2222808464, 2220707664, 2220726364, 2223515264, 2224800564, 2307904064, 2315710664, 2316409064  REF 76000, Lot Numbers: 2209408264, 2210207964, 2211007564, 2213709364, 2214416164, 2211609964, 2215109364, 2216525364, 2215809864, 2217211464, 2217912564, 2220901064, 2303825364, 2304507464, 2305228764, 2305228964, 2305706764, 2312920964, 2321910264, 2308203564, 2313507264, 2314219064  REF 5027, Lot Numbers:2214434964, 2214435064, 2225305264, 2227031164, 2301018164, 2305904064, 2319902764  b) 8887600784, UDI/DI 30884521003396 (cs), 10884521003392 (ea), Lot Numbers:  2215120764, 2215827464.   REF 3044, Lot Number: 2208815964.  REF 2101, Lot Numbers: 2214422964, 2214423064 REF 5029, Lot Numbers: 2204637764, 2208812764, 2208812864, 2217922164  REF 2006, Lot Numbers: 2215118264 REF 2016, Lot Numbers: 2205334564, 2215118364  c)   8887601220, Lot Numbers: 2208901164, 2216807564  REF 76030, Lot Numbers: 2134208364, 2208109364, 2215109564, 2209408664, 2210208364  REF 76010, Lot Numbers: 2132716964, 2132717064, 2133422864, 2133422964, 2134110464, 2134110564, 2208109064, 2211007664, 2211610064, 2212328664,  209408364, 2210208064  REF 76012, Lot Numbers: 2132134964, 2208109164, 2211007764, 2210208164, 2209408464"
    }
  ]
}