BEUDAMED
    FDA Recall Terminated

    ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

    Recall: Z-0938-2021 · Initiated December 18, 2020

    Recall

    Recall Number
    Z-0938-2021
    Event Number
    87048
    Firm
    Alung Technologies Inc
    FEI Number
    3009763347
    Product Code
    QLN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 18, 2020
    Terminated
    May 17, 2021
    Address
    2500 Jane St, Ste 1, Pittsburgh, PA, 15203-2216

    Description

    ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

    Reason

    CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy

    Action

    ALung issued email notification "Recalled CME BodyGuard 323 Infusion Pump to Sapphire Pump Exchange" on 12/18/20 . Letter notifies users of the CME/Sapphire Infusion Pump exchange. Provided with this email are the instructions that will come with the infusion pump package. We wanted to give you a preview of what is coming prior to the packages arriving. Once received, we ask that you promptly remove the current CME pump, package and ship back to ALung. These are needed to be returned to the manufacturer by the end of the year. Reminder you may need to contact biomed for the electrical safety testing of the new Sapphire pump! Please follow your internal protocols.

    Distribution

    US Nationwide distribution.

    Quantity

    101 units