FDAFDA · Alimentos y medicamentos·N.º oficial Z-2371-2014
ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd. LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) STOCKINETIE IMPERVIOUS (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) BAG SUTURE FLORAL LIF (1) BLADE SURGICAL #11 CARBON STEEL (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SYRINGE 30cc SLIP TIP LIF (1) TABLE COVER 44" x 90" (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD UF (1) DRAPE SHEET 41 " x 58" SMS UF (1) NEEDLE HYPODERMIC 22G X 1 Y:z (1) NEEDLE HYPODERMIC 18G X 1 Y:z (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (10) GAUZE SPONGES 4" X 4" 16PL Y 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 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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