BEUDAMED
    FDA Recall Terminated

    Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.

    Recall: Z-0338-06 · Initiated April 19, 2005

    Recall

    Recall Number
    Z-0338-06
    Event Number
    32916
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1824231
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2005
    Posted
    January 6, 2006
    Terminated
    December 6, 2007
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617

    Description

    Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.

    Reason

    The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

    Action

    Consignee was notified via recall letter dated April 19, 2005.

    Distribution

    California, Indiana and North Carolina.

    Quantity

    11