FDAFDA · Food and drugs·Recall number Z-2444-2014
LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) LEGGINS W/7" CUFF 30" X 42" (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINFORCED XLG (1) GOWN LGE STANDARD SMS VELCRO NECK (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4" X 4" 16PLY XRD (2) UTILITY BOWL 16oz (2) STERI STRIP CLOSURE W' X 4" (1) ACTIFOG W/FOAM PAD SOLUTION (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) NEEDLE ULTRA VERES 120MM (1) STAPLE ARTICULATING ECHEL 60MM (1) RELOAD WHITE 60MM ECHELON (1) RELOAD BLUE 60MM ECHELON (2) CANNULA 5MM XCEL SLEEVES (1) TROCAR 5MM BLADELE WITH STAB SLEEVE (1) TROCAR 12MM BLADELE WITH STAB SLEEVE (1) DRAPE LAP. ABDO W/POUCH 102" X 122" X 78" STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Published September 10, 2014 · Recall initiated: May 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Customed, Inc
- Distributor
- 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.
- Lot
- Product code 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.