BEUDAMED
    FDA Recall Terminated

    Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.

    Recall: Z-0260-2007 · Initiated November 17, 2006

    Recall

    Recall Number
    Z-0260-2007
    Event Number
    36850
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1824231
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2006
    Posted
    December 7, 2006
    Terminated
    January 12, 2007
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617

    Description

    Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.

    Reason

    Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

    Action

    The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it.

    Distribution

    New York-single hospital consignee

    Quantity

    5