Z-0734-2016 Class II Terminated
FDA device recall Z-0734-2016 was initiated by Owens & Minor Distribution, Inc. on Nov 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 Sep 13, 2016). Affected quantity: 96266.
Recall details
- Product Type
- Devices
- Report Date
- Feb 10, 2016
- Initiation Date
- Nov 17, 2015
- Termination Date
- Sep 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96266
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: CBN1104 15023H09A Jan-18, CBN1104 15033H09A Feb-18, CBN1104 15043H09A Mar-18, CBN1104 15053H09A Apr-18, CBN1104 15063H09A May-18, CBN1104 15073H09A Jun-18, CBN1104 15083H09A Jul-18, CBN1104 14113H09A Oct-17, CBN1104 14123H09A Nov-17, CBN1104 15013H09A Dec-17, CBN1104 14063H09A May-17, CBN1104 14083H09A Jul-17, CBN1104 14093H09A Aug-17, CBN1104 14053H09A Apr-17, CBN1104 14043H09A Mar-17, CBN1104 14013H09A Dec-16, CBN1104 13053H09A Apr-16, CBN1104 12113H09A Oct-15, CBN1104 13033H09A Feb-16, CBN1104 13083H09A Jul-16, CBN1104 13083H09A Jul-16, CBN1104 13103H09A Sep-16, CBN1104 13113H09A Oct-16, CBN1104 13123H09A Nov-16.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0734-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026