FDAFDA · Alimentos y medicamentos·N.º oficial Z-1048-2024
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 16FR (5.3 MM), 5CC; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 18FR (6.0 MM), 5CC; Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE
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
- a) P4P16CSDK, UDI/DI 20884521174068 (cs), 10884521174061 (ea), Lot Numbers: 2134218264, 2231213064, 2231213164, 2231901164, 2231901264, 2303822464, 2303007064, 2307110664, 2310808164, 2315609464, 2319100364, 2319213064, 2203300964, 2210218464, 2211031564, 2213045564, 2214449364, 2215824164, 2216500464, 2217920064, 2219400664, 2300202064, 2304400364, 2304400464, 2301703364, 2303006964, 2308700564, 2309041264, 2312206464, 2321324164, 2322006864, 2211626864, 2305206264, 2322102764, 2206726164, 2216805064, 2313615064, 2313614964, 2312908364, 2309041264, 2201151164, 2201201664, 2202401464, 2200603564, 2205315264, 2209524264, 2213738964, 2215117864; b) P4P18CSDK, UDI/DI 20884521174075 (cs), 10884521174078(ea), Lot Numbers: 2231213564, 2308004464, 2319100564, 2215824364, 2232517864, 2312206964, 2134218564, 2203931664
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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