FDAFDA · Alimentos y medicamentos·N.º oficial Z-2328-2014
LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD OBSTETRICAL X-LARGE 6" X 96" LIF (3) TOWEL CLAMP (4) DRAPE UTILITY WITH TAPE LIF (1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV (2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINFORCED LIF (1) SURGICAL BLADE #15 CARBON STEEL (1) LITE GLOVE LIF (1) DRESSING NON-ADHESIVE TELFA 4" X 3" (1) TUBE SUCTION CONNECT Y4" X 12' LIF 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 900-484, 25 lots: 110112811 110123129 111010130 111030679 111040976 111051201 111071818 111082100 111092392 111092547 111123258 112020476 112041331 112072873 112083432 112093945 113026060 113026073 113036489 113036802 113067928 113088868 113109845 131210819 140211845
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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