BEUDAMED
    FDA Recall Terminated

    Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40

    Recall: Z-0907-04 · Initiated March 29, 2004

    Recall

    Recall Number
    Z-0907-04
    Event Number
    28904
    Firm
    Allergan Medical Optics Inc
    FEI Number
    3003843509
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2004
    Posted
    July 20, 2004
    Terminated
    November 4, 2004
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40

    Reason

    The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.

    Action

    On March 31, 2004, a product notification letter was mailed to all customers via certified mail. The customers were instructed to stop using, quarantine and return all units. They were instructed to complete the Facsimile form provided and faxed it to the AMO Customer Service at 888-324-0021. They were also instructed to call AMO Customer Service at 800-366-6554 to make arrangement to return the product.

    Distribution

    Distribution was to 67 domestic customers and internationally.

    Quantity

    19, 087