FDAFDA · Food and drugs·Recall number Z-2450-2014
LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4) DRAPE SHEET 44" X 58" SMS LIF (1) TRAY ORGANIZER FULL DEEP (3) SHEET% 53" X 77" REINF. LIF (2) 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
- Product code 900-2290 ,2 lots 112030728 112041301
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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