BEUDAMED
    FDA Recall Terminated

    Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR;Catalog no. TFB-24-88.

    Recall: Z-1170-04 · Initiated June 10, 2004

    Recall

    Recall Number
    Z-1170-04
    Event Number
    29300
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 10, 2004
    Posted
    July 27, 2004
    Terminated
    November 1, 2004
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR;Catalog no. TFB-24-88.

    Reason

    Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

    Action

    The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.

    Distribution

    Nationwide, Canada, Denmark and Japan.

    Quantity

    53