FDAFDA · Food and drugs·Recall number Z-2312-2014
LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) DRAPE T LAPAROTOMY STD SMS (2) SHEET DRAPE 42" X 57" (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE 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 900-176, 48 lots: 110030643 110040905 110081992 111020467 111020499 111030609 111030830 111030932 111051336 111051472 111061512 111071910 111072024 111082068 111092366 111092455 111102645 111112937 111113036 111113163 111123386 111123476 112010091 112010247 112010272 112010285 112020410 112020565 112020570 112030693 112030890 112031006 112041370 112051553 112051879 112062449 112062566 112083377 113099568 131110070 131110404 131110581 131210965 140111413 140211741 140312333 140412794 140513112
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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