Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773
FDA Recall Z-0016-04 · Posted 2003-10-15
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Recalling FirmSmith And Nephew, Inc. Wound Management Division
Recall StatusTerminated
Date Initiated2003-04-15
Date Terminated2012-07-11
Product Quantity3355
Reason for Recall
Product may not meet the established stability specification before the end of labeled expiry date.
Firm 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.
Root Cause
Other
Distribution Pattern
The recalled devices were distributed to 81 direct wholesalers or medical facilities nationwide. There were no direct international or government/military accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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