FDAFDA · Alimentos y medicamentos·N.º oficial Z-2522-2014
Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF ( I) STAPLE SKIN 35 WIDE LIF ( I) TUBE SUCTION CONNECT W' X 12' L/F ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) BLADE # I5 CARBON RIB ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF (2) *PR. GLOVE SURG. 6.5 POWDER LATEX (I) GUT PL FAST ABSORB 5-0 (2) SUTURE 2.0 VICRYL 25MM (3) TOWELS ABSORBENT 15" X 20" 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
- 900-3083, 5 lots: 113109930 131210851 131210953 140111437 140312196
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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