BEUDAMED
    FDA Enforcement Class II Terminated

    Spectrum Medical Quantum Standard heat exchanger

    Recall: Z-2277-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2277-2021
    Event ID
    88267
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    QURA S.R.L.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 18, 2021
    Initiation Date
    March 22, 2021
    Classification Date
    August 12, 2021
    Termination Date
    April 22, 2024
    Address
    Via Di Mezzo 23, N/A, Mirandola, N/A, N/A, 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.

    Code Info

    Batch Numbers: B000129, C000415, C000416, C000417

    Distribution

    US Nationwide distribution in the state of South Carolina.

    Quantity

    1088 units