BEUDAMED
    FDA Enforcement Class I Terminated

    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.

    Recall: Z-0084-2015 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0084-2015
    Event ID
    69181
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2014
    Initiation Date
    September 16, 2014
    Classification Date
    October 31, 2014
    Termination Date
    June 21, 2017
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.

    Reason

    Particulate matter found inside the fluid path.

    Code Info

    Product code: 2B8011 Lot Number: UR13D15112

    Distribution

    Nationwide Distribution including Puerto Rico, and the country of Canada.

    Quantity

    94,224