BEUDAMED
    FDA Recall Terminated

    Spectrum Medical Quantum Standard heat exchanger

    Recall: Z-2277-2021 · Initiated March 22, 2021

    Recall

    Recall Number
    Z-2277-2021
    Event Number
    88267
    Firm
    QURA S.R.L. Via Di Mezzo
    FEI Number
    3016746283
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 22, 2021
    Posted
    August 12, 2021
    Terminated
    April 22, 2024
    Address
    23 Mirandola Italy

    Description

    Spectrum Medical Quantum Standard heat exchanger

    Reason

    Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.

    Action

    The firm notified their consignee of the problem by email beginning on 02/18/2021. They issued a recall noticed on 03/22/2021 by email.

    Distribution

    US Nationwide distribution in the state of South Carolina.

    Quantity

    1088 units