BEUDAMED
    FDA Recall Terminated

    Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

    Recall: Z-0244-2016 · Initiated October 21, 2015

    Recall

    Recall Number
    Z-0244-2016
    Event Number
    72518
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 21, 2015
    Posted
    November 6, 2015
    Terminated
    November 28, 2016
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

    Reason

    Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing.

    Action

    Cook Medical sent an Urgent: Medical Device Recall letter dated October 20, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.

    Distribution

    Worldwide Distribution - US Distribution to the states of : CA, FL, ID, IL, MA, NY, OK, TX, UT and VA., and to the countries of Canada, Austria, Germany, Spain, France, Hungary, Sweden and UK.

    Quantity

    38