BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0550-2024 · Initiated November 15, 2023

    Recall

    Recall Number
    Z-0550-2024
    Event Number
    93376
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FKX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 15, 2023
    Posted
    December 14, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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.

    Action

    Baxter issued an Urgent Medical Device Recall notice to its consignees on 11/15/2023 by US Mail. The notice explained the issue, potential risk, and requested the following: Isolate and cease all use of the affected units pending return.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    339,936 devices