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U.S. Department of Health and Human Services

Class 3 Device Recall Acticoat

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  Class 3 Device Recall Acticoat see related information
Date Initiated by Firm April 15, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 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 2
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 = and Original Applicant = WESTAIM BIOMEDICAL, INC.
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