BEUDAMED
    FDA Recall Open, Classified

    Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

    Recall: Z-1316-2023 · Initiated February 22, 2023

    Recall

    Recall Number
    Z-1316-2023
    Event Number
    91776
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FKX
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    February 22, 2023
    Posted
    April 1, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

    Reason

    The electrical safety testing was not properly performed on the impacted devices and additional testing is required

    Action

    Baxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours.

    Distribution

    US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.

    Quantity

    16 units