BEUDAMED
    FDA Recall Terminated

    Prismaflex System, Prismaflex Control Unit

    Recall: Z-1829-2020 · Initiated February 6, 2020

    Recall

    Recall Number
    Z-1829-2020
    Event Number
    85007
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 6, 2020
    Terminated
    June 1, 2021
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Prismaflex System, Prismaflex Control Unit

    Reason

    Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

    Action

    Baxter is asking customers to: 1. Operators may continue to safely use the Prismaflex control unit according to the warnings and cautions in the Prismaflex Operators Manual. 2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email.

    Distribution

    Distribution in US, Puerto Rico

    Quantity

    1225 units