BEUDAMED
    FDA Enforcement Class II Terminated

    Newton Wire Guide

    Recall: Z-0960-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0960-2018
    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

    Newton Wire Guide

    Reason

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

    Code Info

    Catalog #THSCFNB-/-BH TSCFNA-BH TSCFNB-/-BH TSFNA-/-BH TSFNB-/-BH Affected lots range from: 3733537 - 5803299 F3762971 - F4692445 NS5043714 - NS5900771 3766161 - 5925080 F3753484 - F4887253 NS4938982 - NS5932560 F4556472 - F4718761 NS6024246 3741877 - 5929842 F3749985 - F4903656 NS4928037 - NS5963186 3744567 - 6253002 F3763300 - F4900931 NS4928039 - NS59824 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180

    Distribution

    Nationally

    Quantity

    41,113