Recall Z-2614-2021 ยท NAD Dressing, Wound, Occlusive
ConvaTec, Inc
DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
| Date | Aug 20, 2021 |
| Status | Open, Classified |
| Reason | Primary packaging labeling may be incorrect. |
| Root cause | Environmental control |
| Action | Consignees are notified of the recall via email and letter delivered via UPS. The recalling firm identifies Tier 1 customers as direct consignees and Tier 2 customers and those who receive product from Tier 1 customers. Impacted customers that identify affected product within their inventory are to arrange for return of product through third party Sedgwick. |
| Quantity | 170 packs |
| Distribution | Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.