FDAFDA · Alimentos y medicamentos·N.º oficial Z-2435-2014
KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY (1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL (2) TUBE SUCTION CONNECT. W X 12' LIF (1) CAST PADDING SOFT ROLL 6 X 4yds L/F (2) BANDAGE ELASTIC 6" X 5yds L/F (4) STRIP TAPE 24" X 4" LIF (1) Pk. STERI STRIP CLOSURE Y:z" X 4" LIF (1) SHEET ARTHROSCOPY "T" STD SMS W/POUCH L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) NEEDLE SPINAL ANESTHESIA 18G X 3% LIF (1) SYRINGE 10cc W/0 NDL L/LOCK LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) GOWN IMPERV. XTRA REINF. LGE TIWRAP (1) MAYO STAND COVER REINFORCED LIF (2) NEEDLE HYPODERMIC 25 X 1Y:z LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) STOCKINETTE IMPERV. 14" X 48" LIF (1) TABLE COVER REINF. 50" X 90" LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) SAFETY GLIDE NEEDLE 21G X 1% (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV 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 900-2123, 22 lots 112041293 112041377 112051685 112083162 112093925 112104110 112114603 113015564 113026273 113036460 113036691 113078467 113088788 113109787 131110236 131210645 140111094 140211658 140312117 140412557 140513124 140613657
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.