BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

    Recall: Z-0731-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0731-2016
    Event ID
    72946
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Corporation Englewood
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2016
    Initiation Date
    December 21, 2015
    Classification Date
    January 30, 2016
    Termination Date
    August 18, 2016
    Address
    9540 Maroon Cir Unit 400, N/A, Englewood, CO, 80112-5731, United States

    Description

    Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

    Reason

    All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

    Code Info

    All Lots

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.

    Quantity

    4,695