BEUDAMED
    FDA Recall Terminated

    Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.

    Recall: Z-0395-06 · Initiated December 16, 2005

    Recall

    Recall Number
    Z-0395-06
    Event Number
    34239
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1824231
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2005
    Posted
    January 18, 2006
    Terminated
    February 8, 2007
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617

    Description

    Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.

    Reason

    Sterility is compromised by incomplete package seal.

    Action

    Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.

    Distribution

    Nationwide and Canada.