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Terminated

Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M09, Exu-Dry Dressing, 15" x 9", Smith & Nephew, Inc., Largo, Florida.

FDA Recall Z-1211-2008 · Posted 2008-03-12

Recalling FirmSmith And Nephew, Inc. Wound Management Division
Recall StatusTerminated
Product CodeMCY
Date Initiated2007-11-21
Date Terminated2008-12-15
Product Quantity1,410 dressings

Reason for Recall

Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.

Firm 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

Root Cause

Package design/selection

Distribution Pattern

Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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