FDAFDA · Alimentos y medicamentos·N.º oficial Z-2422-2014
ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAPE UTILITY WITH TAPE L/F ( 1) DENTURE CUP WITH LID ( 1) UTILITY BOWL 16oz. (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F (4) RUBBER BAND ( 1) NEEDLE HYPODERMIC 27G X 1 Y.." ( 1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (3) CAP NURSE 21 " GREEN BOUFFANT (3) MASK SURGICAL BLUE 120MM HG LIF ( 1) PREPPING PAD WITH CUFF (2) TIP ABSORB. APPLIC. STICK SPONGE L/F ( 1) SCALPEL WEIGHTED SAFETY # 11 ( 1) PROBE DRAPE ST 6" X 96" NO GEL LIF ( 1) WRAPPER 30" X 30" (3) TOWELS ABSORBENT 15" X 20" L/F 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 900-1937, 12 lots: 111082312 111113057 112020431 112051902 112062289 113025829 113026168 113067902 113088773 131210660 140211699 140312423
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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