BEUDAMED
    FDA Recall 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 · Initiated June 10, 2021

    Recall

    Recall Number
    Z-2067-2021
    Event Number
    88088
    Firm
    Mercedes Medical, Inc.
    FEI Number
    1000442352
    Product Code
    QBD
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    June 10, 2021
    Terminated
    August 14, 2023
    Address
    12210 Rangeland Parkway, Lakewood Ranch, FL, 34211

    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

    Action

    Letters dated 5/25/2021 were issued via email on 6/10/2021 explaining the reason for recall and safety risks if the kits are used. Return of the kits was requested. A second letter dated 6/29/2021 was issued via email on 6/29/2021 which expanded the recall to include two additional item numbers that were inadvertently excluded from the original letter. The items were sample packs of the products previously recalled.

    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