BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

    Recall: Z-0550-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0550-2024
    Event ID
    93376
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    November 15, 2023
    Classification Date
    December 14, 2023
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

    Reason

    There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

    Code Info

    UDI/DI 0085412153186, Lot Numbers: H23F23028, H23G11054, H23F24018, H23G12029, H23F24034, H23G13100, H23F24067, H23G14074, H23F25049, H23G15048, H23F25056, H23G16038, H23F26047, H23G17051, H23F26054, H23G18067, H23F27037, H23G19115, H23F27045, H23G20055, H23F27102, H23G22069, H23F28035, H23G23067, H23F28043, H23G24107, H23F29066, H23G25047, H23F30064, H23G25096, H23G01030, H23G26094, H23G02046, H23G27100, H23G05015, H23G28082, H23G06047, H23G30054, H23G07052, H23G31110, H23G08050, H23H04032, H23G09058, H23H05039, H23G10072

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    339,936 devices