BEUDAMED
    FDA Enforcement Class II 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 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0485-2018
    Event ID
    78042
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    July 27, 2017
    Classification Date
    January 29, 2018
    Termination Date
    November 3, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    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.

    Code Info

    Product Code 2J8003, Lot No. DR16J18096.

    Distribution

    Distribution in the US and Canada.

    Quantity

    29,088 units