BEUDAMED
    FDA Recall Terminated

    Prismaflex Control Unit

    Recall: Z-2066-2020 · Initiated April 7, 2020

    Recall

    Recall Number
    Z-2066-2020
    Event Number
    85405
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 7, 2020
    Terminated
    November 9, 2021
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Prismaflex Control Unit

    Reason

    Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

    Action

    Baxter notified customers on about 04/07/2020 via "URGENT MEDICAL DEVICE RECALL" letter. The letter instructed customers that the affected units can still be used until the replacement is performed, a local Baxter representative will contact each facility to schedule the replacement of affected devices, complete and return the Baxter Customer Reply Form by scanning and e-mailing it to [email protected], and if the affected devices have been further distributed, to please notify those customers by forwarding a copy of the recall notification. For general questions, contact Baxter Customer Service at 787 866 70 27, between the hours of 7:00 am to 4:00 pm local time, Monday through Friday.

    Distribution

    Distribution only to Puerto Rico and Guam

    Quantity

    5 devices US territories