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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1047-2024

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

Publicado el 28 de febrero de 2024 · Inicio del retiro: 4 de diciembre de 2023

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Cardinal Health 200, LLC
Distribuidor
US and EMEA, Japan, Latin America
Lote
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
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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