Z-0016-04

Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound...

Name: Z-0016-04 Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound...
Creator: Smith And Nephew, Inc. Wound Management Division
Published: 2003-04-15
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2003-04-15 / Terminated / root cause: labeling and UDI

FDA source

Smith And Nephew, Inc. Wound Management Division began a recall of Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773 on 2003-04-15. The reason FDA records is "Product may not meet the established stability specification before the end of labeled expiry date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0016-04
Status: Terminated
Initiated: 2003-04-15
Posted: 2003-10-15
Terminated: 2012-07-11
Recalling firm: Smith & Nephew, Inc.
Product: Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773
Reason for recall: Product may not meet the established stability specification before the end of labeled expiry date.
Root cause tag: labeling and UDI
FDA 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 in commerce: 3355
Distribution: The recalled devices were distributed to 81 direct wholesalers or medical facilities nationwide. There were no direct international or government/military accounts.
Product codes and lots: 021022A, 021023A, 021118A, 030106A, 030107A

K000051UnclassifiedActicoat Foam DressingWestaim Biomedical, Inc. / cleared 2000-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)