BEUDAMED
    FDA Recall Terminated

    Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA

    Recall: Z-0375-06 · Initiated November 30, 2005

    Recall

    Recall Number
    Z-0375-06
    Event Number
    34218
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 30, 2005
    Posted
    January 11, 2006
    Terminated
    September 6, 2006
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA

    Reason

    The integrity of the sterile unit package may become compromised.

    Action

    Consignees were notified via certified mail, return receipt on 11/30/2005. The neonatal recall was faxed to the two consignees with a method to return product.

    Distribution

    AL, AZ, CA, CO, FL, GA, IA, IL, KY, MD, MO, MN, NJ, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WV, WY.

    Quantity

    25 cases (20 units per case)