Smith And Nephew, Inc. Wound Management Division
Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773
| Date | Oct 15, 2003 (initiated Apr 15, 2003) |
| Status | Terminated |
| Reason | Product may not meet the established stability specification before the end of labeled expiry date. |
| Root cause | Other |
| Action | A Recall notification with a Response Form was mailed first class with return reciept requested on April 15, 2003 to direct accounts. The recall was to the wholesale distributor level only. The accounts were asked to check their stock immediately and to return recalled product to the Recalling Firm in Largo, FL. Non responding accounts were sent follow-up Recall Notifications letters. |
| Quantity | 3355 |
| Distribution | The recalled devices were distributed to 81 direct wholesalers or medical facilities nationwide. There were no direct international or government/military accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000051 | ACTICOAT FOAM DRESSING Westaim Biomedical, Inc., Apr 5, 2000 |