BEUDAMED
    FDA Recall Terminated

    Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices.

    Recall: Z-0623-2010 · Initiated August 25, 2009

    Recall

    Recall Number
    Z-0623-2010
    Event Number
    53953
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 25, 2009
    Posted
    January 13, 2010
    Terminated
    August 11, 2010
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices.

    Reason

    Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).

    Action

    Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition. Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.

    Distribution

    Nationwide distribution.

    Quantity

    145 units