BEUDAMED
    FDA Recall Terminated

    Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.

    Recall: Z-0930-05 · Initiated April 26, 2005

    Recall

    Recall Number
    Z-0930-05
    Event Number
    31856
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1824231
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 26, 2005
    Posted
    June 25, 2005
    Terminated
    October 26, 2005
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617

    Description

    Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.

    Reason

    The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.

    Action

    Consignees were notified via letter dated 4/26/05.

    Distribution

    Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.

    Quantity

    48