BEUDAMED
    FDA Recall Terminated

    THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label)

    Recall: Z-0135-2008 · Initiated August 15, 2007

    Recall

    Recall Number
    Z-0135-2008
    Event Number
    44879
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 15, 2007
    Posted
    February 6, 2008
    Terminated
    April 21, 2008
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label)

    Reason

    The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.

    Action

    Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product.

    Distribution

    Worldwide Distribution - USA, Australia, India, Trinidad and Tobago.

    Quantity

    33