BEUDAMED
    FDA Recall Terminated

    Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates.

    Recall: Z-1079-03 · Initiated June 13, 2003

    Recall

    Recall Number
    Z-1079-03
    Event Number
    26542
    Firm
    Ballard Medical Products
    FEI Number
    1719891
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 13, 2003
    Posted
    August 6, 2003
    Terminated
    November 24, 2003
    Address
    12050 S Lone Peak Parkway, Draper, UT, 84020

    Description

    Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates.

    Reason

    Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.

    Action

    All consignees were notified by letter on 06/13/2003.

    Distribution

    Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.

    Quantity

    1565 units