BEUDAMED
    FDA Enforcement Class II Terminated

    Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209

    Recall: Z-1948-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1948-2021
    Event ID
    87954
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Action Industries, Inc. 306
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 30, 2021
    Initiation Date
    May 11, 2021
    Classification Date
    June 24, 2021
    Termination Date
    May 10, 2023
    Address
    25 Heywood Rd, N/A, Arden, NC, 28704-9302, United States

    Description

    Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209

    Reason

    There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

    Code Info

    Batch Numbers: 0000277610, Exp. 04/15/2022; 0000276879, Exp. 04/15/2022

    Distribution

    US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.

    Quantity

    102 cases of 20 units