BEUDAMED
    FDA Recall Terminated

    Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.

    Recall: Z-0828-03 · Initiated April 30, 2003

    Recall

    Recall Number
    Z-0828-03
    Event Number
    26188
    Firm
    Aspen Surgical Products, Inc.
    FEI Number
    3002750084
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 30, 2003
    Posted
    May 15, 2003
    Terminated
    November 13, 2003
    Address
    7425 Clyde Park SW, Ste. G, Byron Center, MI, 49315

    Description

    Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.

    Reason

    Sterility compromised - incomplete sterile package seal.

    Action

    The firm called each customer on 4/30/03 and requested that the product be returned. Distributors were asked to notify their customers of the recall.

    Distribution

    Nationwide, Japan and United Kingdom.

    Quantity

    299 boxes