BEUDAMED
    FDA Enforcement Class I Terminated

    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures

    Recall: Z-1258-2021 · Reported April 7, 2021

    Enforcement

    Recall Number
    Z-1258-2021
    Event ID
    86808
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smisson-Cartledge Biomedical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 7, 2021
    Initiation Date
    February 18, 2021
    Classification Date
    March 26, 2021
    Termination Date
    April 26, 2024
    Address
    487 Cherry St, Third Street Tower, Macon, GA, 31201-7972, United States

    Description

    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures

    Reason

    Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

    Code Info

    Model PTC-1200, GTIN (01)00857893006059, all serial numbers

    Distribution

    Nationwide Distribution in US and international via 2 US distributors (VA and GA)

    Quantity

    18482 devices