BEUDAMED
    FDA Enforcement Class II Terminated

    Amplatz Ultra Stiff Wire Guide

    Recall: Z-0950-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0950-2018
    Event ID
    79195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    October 13, 2017
    Classification Date
    March 9, 2018
    Termination Date
    October 23, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Amplatz Ultra Stiff Wire Guide

    Reason

    Label does not state that the product is heparin-coated.

    Code Info

    Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894

    Distribution

    Nationally

    Quantity

    12,462