BEUDAMED
    FDA Recall Terminated

    Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.

    Recall: Z-0378-2007 · Initiated December 15, 2006

    Recall

    Recall Number
    Z-0378-2007
    Event Number
    37051
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1824231
    Product Code
    KAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2006
    Posted
    January 25, 2007
    Terminated
    December 4, 2007
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617

    Description

    Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.

    Reason

    The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

    Action

    Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.

    Distribution

    Worldwide, including USA, Canada, Netherlands and United Kingdom.

    Quantity

    117