{ "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-1046-2024", "product_description": "Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML SYRINGE; Dover HYDROGEL COATED LATEX FOLEY TRAY 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover SILICONE COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover SILICONE COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover URINE METER ADD-A-FOLEY TRAY, 400 ML, TOP VENT, LUER-LOCK SAMPLING, DRAIN SPOUT, PREP TRAY; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2-WAY, CATH SECUREMENT; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 14 FR (4.7 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY, 30 ML LUBE SYRINGE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT ; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover 100% SILICONE 200 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLELESS SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover\" 100% SILICONE FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE SILVERHYDROGEL FOLEY TRAY; Dover Silicone 100% 16FR/18F; Dover 100% Silver Hydro tray", "product_quantity": "435060 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) 6140, 30884521015214 (cs), 10884521015210 (ea), UDI/DI Lot Numbers: 2206723264, 2310813264, 2213047664, 2213301264, 2211624264 2205319164, 2209519564, 2218504964; b) 6148LL, UDI/DI 30884521015528 (cs), 10884521015524 (ea), Lot Numbers: 2210903364, 2308701264, 2310107364, 2212900264, 2212900364; c) 6153, UDI/DI 30884521015252 (cs), 10884521015258 (ea), Lot Numbers: 2206007764, 2222830664, 2233605264, 2300125764, 2300125864, 2300132664, 2314302964, 2205201164, 2206007864, 2213047864, 2223545264, 2304402364, 2317731064, 2211628564, 2205329464, 2205328764, 2213742064, 2216533964; d) 6154, UDI/DI 20884521015262 (cs), 10884521015265 (ea), Lot Numbers: 2233605364, 2206011164, 2309042764, 2217922664; e) 8949, UDI/DI 30884521015399 (cs), 10884521015395 (ea), Lot Numbers: 2206903964, 2206904064, 2313507764, 2313507864, 2322322564, 2223546964, 2306613764, 2205201264, 2310108164, 2205320964, 2209526764; f) PP14SD, UDI/DI 20884521029672 (cs), 10884521029675 (ea), Lot Numbers: 2301030764, 2216500164, 2309039464, 2314220064, 2203931264, 2317729764, 2200119164, 2200427964, 2201132564, 2215117664; g) PP16SD, UDI/DI 20884521029696 (cs), 10884521029699 (ea), Lot Numbers: 2213738864, 2313806164, 2321617264, 2303818764, 2304400164, 2301023064, 2301023164, 2307110464, 2308004064, 2310901664, 2310901864, 2314306964, 2318416964, 2319218264, 2203928664, 2210901564, 2209524064, 2216500264, 2216533864, 2304400264, 2302000364, 2302401364, 2302401464, 2313100464, 2313806064, 2215111764, 2215111864, 2216801464, 2305903064, 2134217964, 2200119064, 2200428064, 2201132664, 2204633564, 2204633664, 2208814464, 2215823864; h) PP18SD, UDI/DI 20884521029719 (cs), 10884521029712 (ea), Lot Numbers: 2303822164, 2310807864, 2212321464, 2317729964, 2203931364 i) 3718, Lot Numbers: 2303815264, 2307202164, 2209534664, 2223544564, 2219402664, 2220726564, 2206727764, 2201131264, 2203933064, 2209525464, 2210232964, 2217921964 j) 3716, 2203930364, 2206718464, 2213046664, 2222114064, 2222114164, 2222830064, 2303815064, 2303815164, 2308002764, 2307109164, 2307109264, 2308002564, 2314901264, 2314901364, 2206718364, 2209530364, 2214452164, 2215825964, 2218612564, 2304401864, 2304701764, 2305203064, 2308002664, 2308700864, 2308719164, 2211621264, 2211621364, 2210900964, 2210901064, 2216502664, 2310107164, 2207404064, 2310301864, 2200120364, 2200120464, 2200429564, 2200429664, 2203930464, 2203930564, 2204635764, 2204635864, 2205317964, 2205318064, 2206024964, 2206025064, 2208812264, 2209101864, 2212301864, 2212301964, 2216806264, 2217921864 k) PP18ULD, Lot Numbers: 2215117764, 2312205864 l) PP16ULD, Lot Numbers: 2209514764, 2209514864, 2214449264, 2217919664, 2308700364, 2311521264, 2317729864, 2313805964, 2322321364, 2208814564, 2215823964 n) 8324, Lot Number: 2210221064 o) 7020LL, Lot Numbers: 2303824064, 2210220864, 2223546364, 2232613764, 2312912164, 2209526064, 2215826864 p) 6080, Lot Number: 2214452564 q) PP16XSD, Lot Numbers: 2301030964, 2204633764, 2207402364, 2219310764, 2302405264, 2312205764, 2217919764 r) 6144ICLL, UDI/DI 30884521009121 (cs), 10884521009127 (ea) Lot Numbers: 2216802364, 2208800564, 2307111564 s) 6148LL, Lot Numbers: 2210903364, 2308701264, 2310107364, 2212900264, 2212900364 t) 6155, Lot Numbers: 2205319564, 2205328664, 2216802264, 2318417664, 2213047964, 2312208664, 2312208864, 2313100564, 2313100664, 2210903464, 2310107464 u) 3532, Lot Numbers: 2213741364, 2306612564, 2314901664 v) 6014, Lot Numbers: 2211030964, 2308700964, 2309042564, 2308900664, 2216806564, 2205318964, 2215119764" } ] }