BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1211-2008 · Initiated November 21, 2007

    Recall

    Recall Number
    Z-1211-2008
    Event Number
    45901
    Firm
    Smith And Nephew, Inc. Wound Management Division
    FEI Number
    3006760724
    Product Code
    MCY
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    November 21, 2007
    Posted
    March 12, 2008
    Terminated
    December 15, 2008
    Address
    11775 Starkey Road, Largo, FL, 33773-4727

    Description

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

    Reason

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

    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

    Distribution

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

    Quantity

    1,410 dressings