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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cardinal Health 200, LLC
- Reason for Recall:
- Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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 Codes/Lot Numbers:
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
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1047-2024
Related Recalls
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Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.