Device product
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
Z-0735-2016
Product summary
- Event
- Event 72910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64011
- Official record key
device-enforcement:Z-0735-2016
Official wording
Reason: MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
Code information: Item No. Lot No. Expiration Date, CBN1106 12113H10A Oct-15, CBN1106 13033H10A Feb-16, CBN1106 13053H10A Apr-16, CBN1106 13083H10A Jul-16, CBN1106 13103H10A Sep-16, CBN1106 13113H10A Oct-16, CBN1106 14013H10A Dec-16, CBN1106 14043H10A Mar-17, CBN1106 14053H10A Apr-17, CBN1106 14063H10A May-17, CBN1106 14083H10A Jul-17, CBN1106 14093H10A Aug-17, CBN1106 14093H10A Aug-17, CBN1106 14113H10A Oct-17, CBN1106 14123H10A Nov-17, CBN1106 15013H10A Dec-17, CBN1106 15023H10A Jan-18, CBN1106 15033H10A Feb-18, CBN1106 15043H10A Mar-18, CBN1106 15053H10A Apr-18, CBN1106 15063H10A May-18, CBN1106 15083H10A Jul-18, CBN1106 15073H10A Jun-18.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Microbial contamination
microbial contamination