FDAFDA · Food and drugs·Recall number Z-2522-2014
Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF ( I) STAPLE SKIN 35 WIDE LIF ( I) TUBE SUCTION CONNECT W' X 12' L/F ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) BLADE # I5 CARBON RIB ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF (2) *PR. GLOVE SURG. 6.5 POWDER LATEX (I) GUT PL FAST ABSORB 5-0 (2) SUTURE 2.0 VICRYL 25MM (3) TOWELS ABSORBENT 15" X 20" LIF 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
- 900-3083, 5 lots: 113109930 131210851 131210953 140111437 140312196
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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