BEUDAMED
    FDA Enforcement Class II Terminated

    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

    Recall: Z-2067-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2067-2021
    Event ID
    88088
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mercedes Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    June 10, 2021
    Classification Date
    July 12, 2021
    Termination Date
    August 14, 2023
    Address
    12210 Rangeland Parkway, Lakewood Ranch, FL, 34211, United States

    Description

    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

    Reason

    No 510(k) clearance

    Code Info

    All lots.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas. Government distribution was made but no military distribution.

    Quantity

    SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs