BEUDAMED
    FDA Recall Terminated

    Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.

    Recall: Z-0665-2007 · Initiated February 28, 2007

    Recall

    Recall Number
    Z-0665-2007
    Event Number
    37568
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2007
    Posted
    March 29, 2007
    Terminated
    May 29, 2007
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.

    Reason

    Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.

    Action

    Consignees were notified via telephone on 2/28/07 and instructed to return the product.

    Distribution

    Illinois, North Carolina and South Carolina.

    Quantity

    20 units