BEUDAMED
    FDA Recall Terminated

    Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    Recall: Z-1178-2010 · Initiated May 6, 2009

    Recall

    Recall Number
    Z-1178-2010
    Event Number
    53474
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 6, 2009
    Posted
    March 22, 2010
    Terminated
    March 30, 2012
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    Reason

    Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.

    Action

    Abbott Vascular issued an "Urgent Device Recall" notification dated May 7, 2009. Consignees were informed of the affected product and instructed to work with local sales representatives in identifying any unused devices and arrange for return to the firm. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.

    Distribution

    Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.

    Quantity

    26