Class 3 Device Recall Acticoat

• Date Initiated by Firm: April 15, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on July 11, 2012
• Recall Number: Z-0016-04
• Recall Event ID: 26318
• 510(K)Number: K000051
• Product: Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773
• Code Information: 021022A, 021023A, 021118A, 030106A, 030107A
• Recalling Firm/ Manufacturer: Smith And Nephew, Inc. Wound Management Division; 11775 Starkey Rd; Largo FL 33773
• For Additional Information Contact: Jim Irwin; 800-876-1261
• Manufacturer Reason for Recall: Product may not meet the established stability specification before the end of labeled expiry date.
• FDA Determined 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code =