FDAFDA · Food and drugs·Recall number Z-2471-2014
EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110" X 77" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP 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 900-2498 , 4 lots 112020356 112051968 112072870 113078527
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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