Recall Z-2519-2021 ยท NAD Dressing, Wound, Occlusive
ConvaTec, Inc
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
| Date | Aug 9, 2021 |
| Status | Open, Classified |
| Reason | There is a potential for open seals which can compromise sterility. |
| Root cause | Process control |
| Action | Customer notification was made via email and via UPS letter. Distributors are asked to stop distributing and quarantine all recalled lots. All customers are notified that a Recall Response Form is to be completed and returned to the recalling firm. All impacted product is to be returned via third party Sedgwick, Indianapolis, IN. If product was further distributed, the customer shall forward the recall notification letter and ask subaccounts to follow the recall instructions. |
| Quantity | 2,734,830 units |
| Distribution | International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesia, Iran, Malaysia, Mexico, Myanmar, Nicaragua, New Zealand, Panama, Peru, , Pakis |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.