Recall Z-0004-2014 ยท MXE
ASO, LLC
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
| Date | Oct 1, 2013 (initiated Aug 21, 2013) |
| Status | Terminated |
| Reason | No antibacterial bandages were packed in boxes labeled as antibacterial. |
| Root cause | Labeling Change Control |
| Action | A letter was sent via e-mail and mail to the only customer on August 23, 2013 that a recall of two lots was in progress and to examine their inventory and stop distribution of the product. Product was to be either place in quarantine or destroyed. A credit for all returned product or by returned completed certificate of destruction. |
| Quantity | 37 cases (72 retail boxes in each case) |
| Distribution | Distributed in the states of ID, WI, IN, and NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.