FDAFDA · Food and drugs·Recall number Z-2391-2014
PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F 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 900-1402, 14 lots: 112041394 112051751 112072866 112093870 112124944 113036451 113046933 113057834 113088696 113088831 131110172 140111093 140412599 140513083
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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