FDAFDA · Alimentos y medicamentos·N.º oficial Z-2341-2014
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT TOWELS 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 50" X 90" UF (1) ABDOMINAL DRAPE WITH TAPE UF (1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) PAD OBSTETRICAL XL LIF (2) SPECIMEN CONTAINER 4oz. W/LID & LABEL (1 ) SYRINGE 1 Occ PREFILLED W/GEL (1 ) DRAPE SHEET 41 " X 69" MEDIUM UF (1 ) CATHETER 14FR. ROB. NELAT (1) NON-ADHESIVE TELFA DRESSING (2) GOWN IMP. REINFORCED LGE SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Publicado el 10 de septiembre de 2014 · Inicio del retiro: 20 de mayo de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Customed, Inc
- Distribuidor
- Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
- Lote
- Product code 900-635, 42 lots: 110040968 110051274 110051406 110092404 110112815 110112897 111020476 111030646 111041113 111051299 111061558 111071830 111082247 111092399 111102773 111112950 111123278 112020492 112041343 112083439 112093730 112125105 112125304 113015514 113036673 113036736 113047027 113057609 113067934 113068178 113088881 113099448 113109866 113507497 131110310 131210835 140111242 140211675 140211944 140312385 140412840 140513250
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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