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Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, ...

FDA Recall #Z-1047-2024 — Class I — December 4, 2023

Recall #Z-1047-2024 Date: December 4, 2023 Classification: Class I Status: Ongoing

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

Reason for Recall

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Recalling Firm

Cardinal Health 200, LLC — Waukegan, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

7800 units

Distribution

US and EMEA, Japan, Latin America

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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