Z-0735-2016 Class II Terminated
FDA device recall Z-0735-2016 was initiated by Owens & Minor Distribution, Inc. on November 17, 2015 and is designated Class II. Reason for recall: MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. The recall status is terminated (terminated September 13, 2016). Affected quantity: 64011.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2016
- Initiation Date
- November 17, 2015
- Termination Date
- September 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64011
Product Description
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.
Reason for Recall
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
Distribution Pattern
Nationwide Distribution.
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.