BEUDAMED
    FDA Recall Terminated

    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

    Recall: Z-0485-2018 · Initiated July 27, 2017

    Recall

    Recall Number
    Z-0485-2018
    Event Number
    78042
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 27, 2017
    Posted
    January 11, 2018
    Terminated
    November 3, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

    Reason

    A leak may allow for microbial contamination of the sterile fluid path.

    Action

    US consignees were notified via letter on July 27, 2017 and Canadian consignees were notified on July 31, 2017. Instructions included to locate and remove all affected product from the facility, contact Baxter Healthcare to arrange for return of product, complete and return the Reply Form, and to notify customers if the product was further distributed. For further questions, please call (800) 422-9837.

    Distribution

    Distribution in the US and Canada.

    Quantity

    29,088 units