BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    Recall: Z-2379-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2379-2021
    Event ID
    88351
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    July 22, 2021
    Classification Date
    August 27, 2021
    Termination Date
    January 17, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    Reason

    Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming

    Code Info

    Lot Numbers: 20B2330M

    Distribution

    US Nationwide distribution.

    Quantity

    1976 units