BEUDAMED
    FDA Recall Terminated

    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    Recall: Z-2378-2021 · Initiated July 22, 2021

    Recall

    Recall Number
    Z-2378-2021
    Event Number
    88351
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    July 22, 2021
    Terminated
    January 17, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) 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

    Action

    The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.

    Distribution

    US Nationwide distribution.

    Quantity

    64275 units