| Class 2 Device Recall ExuDry Wound Dressing | |
Date Initiated by Firm | November 21, 2007 |
Date Posted | March 12, 2008 |
Recall Status1 |
Terminated 3 on December 15, 2008 |
Recall Number | Z-1209-2008 |
Recall Event ID |
45901 |
Product Classification |
Wound Burn Dressing - Product Code MCY
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Product | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999018, Exu-Dry Dressing, 15" x 18",
Smith & Nephew, Inc.,Largo, Florida. |
Code Information |
Lot Number; 70501 |
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 | 2040 dressings |
Distribution | Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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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