BEUDAMED
    FDA Recall Terminated

    Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.

    Recall: Z-0927-03 · Initiated February 20, 2003

    Recall

    Recall Number
    Z-0927-03
    Event Number
    25650
    Firm
    Portex, Inc
    FEI Number
    1824231
    Product Code
    KOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 20, 2003
    Posted
    June 12, 2003
    Terminated
    December 10, 2003
    Address
    5700 West 23rd Ave, Gary, IN, 46406

    Description

    Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.

    Reason

    May have incorrectly printed graduation markings along the tube shaft.

    Action

    A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.

    Distribution

    Nationwide, England and France

    Quantity

    49