Z-0004-2014 Class II Terminated
FDA device recall Z-0004-2014 was initiated by ASO, LLC on Aug 21, 2013 and is designated Class II. Reason for recall: No antibacterial bandages were packed in boxes labeled as antibacterial. The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 37 cases (72 retail boxes in each case).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2013
- Initiation Date
- Aug 21, 2013
- Termination Date
- Aug 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 cases (72 retail boxes in each case)
Product Description
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Reason for Recall
No antibacterial bandages were packed in boxes labeled as antibacterial.
Distribution Pattern
Distributed in the states of ID, WI, IN, and NE.
Code Information
UPC Code #: 400129133311 Lot numbers: 330543 and 341383