Recall Z-0735-2016 ยท KGX Tape And Bandage, Adhesive
Owens & Minor Distribution, Inc.
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.
| Date | Jan 30, 2016 (initiated Nov 17, 2015) |
| Status | Terminated |
| Reason | MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. |
| Root cause | Under Investigation by firm |
| Action | The firms recall strategy is as follows : recall was initiated by the Owens & Minor Home Office Recall Officer. The Home Office Recall Officer e-mailed the following documents to the Distribution Center (DC) Recall Officer at each affected DC: 1. DC Recall Letter (specific instructions for the DCs), 2. Recall Inventory Report form (for the DCs to record the amount of affected product quarantined), 3. Customer Letter (specific instructions for the customers), 4. Recall Return Response Form (for the customers to report back the details of the quantity of affected product in their inventory), 5 |
| Quantity | 64011 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.