BEUDAMED
    FDA Enforcement Class II Ongoing

    GEM Coupler Forceps, GEM4183C, packaged individually.

    Recall: Z-0680-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0680-2019
    Event ID
    81581
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    November 2, 2018
    Classification Date
    December 22, 2018
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    GEM Coupler Forceps, GEM4183C, packaged individually.

    Reason

    Potential presence of rust on Coupler Forceps (GEM4183C).

    Code Info

    Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850

    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