Class 2 Device Recall ExuDry Wound Dressing

• Date Initiated by Firm: November 21, 2007
• Date Posted: March 12, 2008
• Recall Status: Terminated on December 15, 2008
• Recall Number: Z-1215-2008
• Recall Event ID: 45901
• Product Classification: Wound Burn Dressing - Product Code MCY
• Product: Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M37, Exu-Dry Pad 24"x36" Non-Permeable Medium Absorbency, Smith & Nephew, Inc.,Largo, Florida.
• Code Information: Lot Numbers; 70414, 70521, 70621, and 70708.
• 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: 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: 18,864 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.