BEUDAMED
    FDA Enforcement Class II Terminated

    Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices

    Recall: Z-0865-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0865-2016
    Event ID
    73163
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    January 20, 2016
    Classification Date
    February 24, 2016
    Termination Date
    November 21, 2016
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices

    Reason

    Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.

    Code Info

    Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304

    Distribution

    Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.

    Quantity

    25