FDAFDA · Alimentos y medicamentos·N.º oficial Z-2453-2014
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUCTION CONNECT. W' X 12' LIF (1) GOWN SURG REINF XL T/WRAP (20) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) PENCIL CAUTERY HAND SWITCHING (1) PVP PAINT 8" STICK SPONGE (1) PVP SCRUB 8" STICK SPONGE (1) SYRINGE 20cc W/0 NDL LUER LOCK LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) PRE PAD WITH CUFF (1) PACKING VAGINAL XRD 4" X 36" 8PLY (2) PAD OBSTETRICAL XL (1) CATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON NON WOVEN LIF Product Usage: 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 900-2385 ,7 lots 112041304 112093771 113057712 113078586 113099428 120051955 140613805
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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