BEUDAMED
    FDA Recall Terminated

    Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.

    Recall: Z-0339-2007 · Initiated August 31, 2006

    Recall

    Recall Number
    Z-0339-2007
    Event Number
    36693
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1824231
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2006
    Posted
    January 5, 2007
    Terminated
    May 4, 2007
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617

    Description

    Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.

    Reason

    Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.

    Action

    Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall.

    Distribution

    Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.

    Quantity

    197