BEUDAMED
    FDA Enforcement Class II Terminated

    Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.

    Recall: Z-0109-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0109-2014
    Event ID
    66222
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    August 30, 2013
    Classification Date
    October 29, 2013
    Termination Date
    April 19, 2017
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.

    Reason

    Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471

    Code Info

    R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070

    Distribution

    Nationwide distribution.

    Quantity

    49,344 units