FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0016-04
- Recalling firm
- Smith And Nephew, Inc. Wound Management Division
- Product
- Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773
- Status
- Terminated
- Initiated
- 2003-04-15
- Posted
- 2003-10-15
- Terminated
- 2012-07-11
- 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.
- Lot, serial or model codes
- 021022A, 021023A, 021118A, 030106A, 030107A
- 510(k) numbers
- ["K000051"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3006760724
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28