Z-0733-2016 Class II Terminated
FDA device recall Z-0733-2016 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: 42,050.
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
- 42,050
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: 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0733-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026