BEUDAMED
    FDA Enforcement Class I Terminated

    Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.

    Recall: Z-2005-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2005-2021
    Event ID
    87406
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Eight Medical International BV
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 4, 2021
    Initiation Date
    June 4, 2021
    Classification Date
    July 23, 2021
    Termination Date
    August 3, 2023
    Address
    Laan Van Hildernisse-Noord 2a, N/A, Bergen Op Zoom, N/A, N/A, Netherlands

    Description

    Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.

    Reason

    The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

    Code Info

    UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686

    Distribution

    US Nationwide, Colombia, and Dubai.

    Quantity

    22