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U.S. Department of Health and Human Services

Class 2 Device Recall ExuDry Wound Dressing

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  Class 2 Device Recall ExuDry Wound Dressing see related information
Date Initiated by Firm November 21, 2007
Date Posted March 12, 2008
Recall Status1 Terminated 3 on December 15, 2008
Recall Number Z-1213-2008
Recall Event ID 45901
Product Classification Wound Burn Dressing - Product Code MCY
Product Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M24, Exu-Dry Dressing, 15" x 24",
Smith & Nephew, Inc.,Largo, Florida.
Code Information Lot Number: 70518
Recalling Firm/
Manufacturer
Smith And Nephew, Inc. Wound Management Division
11775 Starkey Road
Largo FL 33773-4727
For Additional Information Contact
727-399-3785
Manufacturer Reason
for Recall
Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.
FDA Determined
Cause 2
Package design/selection
Action Consignees were notified of recall by certified mail, Urgent Device Recall letter dated 11/21/2007, which was sent to each consignee. The recalled product will be returned to the firm by pre-paid FedEX return labels. A second letter is to be issued to each distributor for recall to the retail level, as the firm's original recall strategy of distributor level recall, was deemed inappropriate by CDRH
Quantity in Commerce 1,710 dressings
Distribution Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada.
Total Product Life Cycle TPLC Device Report

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.
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