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-0733-2016
Product summary
- Event
- Event 72910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,050
- Official record key
device-enforcement:Z-0733-2016
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: CBN1103 12113H08A Oct-15, CBN1103 13033H08A Feb-16, CBN1103 13053H08A Apr-16, CBN1103 14013H08A Dec-16, CBN1103 14043H08A Mar-17, CBN1103 14053H08A Apr-17, CBN1103 14083H08A Jul-17, CBN1103 14063H08A May-17, CBN1103 15013H08A Dec-17, CBN1103 14123H08A Nov-17, CBN1103 14113H08A Oct-17, CBN1103 15023H08A Jan-18, CBN1103 15033H08A Feb-18, CBN1103 15043H08A Mar-18, CBN1103 15053H08A Apr-18, CBN1103 15063H08A May-18, CBN1103 15073H08A Jun-18, CBN1103 15083H08A Jul-18.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Microbial contamination
microbial contamination