FDAFDA · Food and drugs·Recall number Z-2451-2014
FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15 CARBON RIB (1) SHEET ENT SPLIT 110" X 77" SMS L/F (3) *Pr. GLOVE PERRY SURG # 7.5 LATEX (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (2) COTTON BALL MED (3) *Pr. GLOVE PERRY SURG # 7 LATEX (1) DRAPE INST. MAGNETIC 10" X 16" L/F (2) NEEDLE 30G X 1 DISP LIF (1) MARKER SKIN WITH RULER LIF (4) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) COUNTER NEEDLE AND BLADE 15C FOAM I MAG STRIP LIF (2) GOWN SOFT SMS STD X-LGE SET IN SLEEVE LIF (1) RULER 6" FLEXIBLE (1) BAG ZIP LOCK 6" X 10" PLASTIC 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 900-2291 ,2 lots 112010139 112020467
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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