BEUDAMED
    FDA Recall Terminated

    Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia

    Recall: Z-1144-2007 · Initiated June 4, 2007

    Recall

    Recall Number
    Z-1144-2007
    Event Number
    38226
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 4, 2007
    Posted
    August 8, 2007
    Terminated
    June 12, 2008
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia

    Reason

    The tubes may kink during use which may impede or prevent ventilation.

    Action

    Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.

    Distribution

    Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.

    Quantity

    4376 cases (43760 units/total for both products)