BEUDAMED
    FDA Recall Open, Classified

    GEM Coupler Forceps, GEM4183C, packaged individually.

    Recall: Z-0680-2019 · Initiated November 2, 2018

    Recall

    Recall Number
    Z-0680-2019
    Event Number
    81581
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    HTD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 2, 2018
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    GEM Coupler Forceps, GEM4183C, packaged individually.

    Reason

    Potential presence of rust on Coupler Forceps (GEM4183C).

    Action

    Synovis Micro Companies Alliance (MCS), Inc. a subsidiary of Baxter International Inc., notified customers on about 11/02/2018 via "Urgent Product Recall letter sent via U.S.P.S., first class mail. Instructions included to review inventory for affected product, arrange for return of all affected product to Synovis MCA, complete and return the provided Baxter customer reply form, and notify customers if the affected product was further distributed. General questions can be directed to Synovia MCA at 800-510-3318 or 205-941-0111 Monday through Friday, between 8:00 am and 5:00 pm Central Time.

    Distribution

    Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia

    Quantity

    123 devices