BEUDAMED
    FDA Recall Terminated

    Intraoperative Ultrasound Cover Kit

    Recall: Z-0718-05 · Initiated November 3, 2004

    Recall

    Recall Number
    Z-0718-05
    Event Number
    30396
    Firm
    Bard Access Systems, Inc
    FEI Number
    3006260740
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2004
    Posted
    April 22, 2005
    Terminated
    April 22, 2005
    Address
    5425 Amelia Earhart Dr, Salt Lake City, UT, 84116-3713

    Description

    Intraoperative Ultrasound Cover Kit

    Reason

    Conductivity gel pouches, labeled as sterile, and packaged in various kits may not be sterile.

    Action

    All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.

    Distribution

    Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    8,561 units