Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division,
FDA device recall Z-0016-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Smith And Nephew, Inc. Wound Management Division
- Reason for recall
- Product may not meet the established stability specification before the end of labeled expiry date.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 3355
- Distribution
- The recalled devices were distributed to 81 direct wholesalers or medical facilities nationwide. There were no direct international or government/military accounts.
- Date initiated
- 2003-04-15
- Date posted
- 2003-10-15
- Date terminated
- 2012-07-11
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTICOAT FOAM DRESSING (K000051) | Westaim Biomedical, Inc. | 2000-04-05 |