BEUDAMED
    FDA Recall Terminated

    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.

    Recall: Z-2101-2015 · Initiated May 28, 2015

    Recall

    Recall Number
    Z-2101-2015
    Event Number
    71430
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 28, 2015
    Posted
    July 18, 2015
    Terminated
    May 30, 2017
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.

    Reason

    Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.

    Action

    Written recall communication letters were shipped via FedEx on June 05, 2015 to all US Consignees. Customers were asked to complete and return response forms and recalled products. Recalled devices will be held for final disposition and destruction. Customers wree asked to forward notices if recalled devices were further distributed. Effectivenes checks will be conducted by mail, phone and visits. Customers may contact Cook Medical Relations (800) 457-4500 or 1 (812)- 339-2235 Monday through Friday from 7:30 AM to 5:00 PM or e-mail at CustomerrelationsNA@cook medical.com.

    Distribution

    Worldwide Distribution - US Nationwide in the state of: AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada and EU.

    Quantity

    661