BEUDAMED
    FDA Recall Terminated

    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

    Recall: Z-1417-2021 · Initiated February 16, 2021

    Recall

    Recall Number
    Z-1417-2021
    Event Number
    87575
    Firm
    Vectornate USA Inc
    FEI Number
    3015989005
    Product Code
    JSG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 16, 2021
    Terminated
    December 8, 2022
    Address
    10 Industrial Ave, Ste 4, Mahwah, NJ, 07430-2284

    Description

    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

    Reason

    Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

    Action

    The firm did not give out a public statement of a recall or recall strategy as it only affected one client and was specific to two identified lots. the firm did notify the customer of the issue via phone and email.

    Distribution

    US Nationwide distribution in the state of NJ.

    Quantity

    130,000 devices