BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.

    Recall: Z-1945-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1945-2014
    Event ID
    68640
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    July 9, 2014
    Initiation Date
    July 8, 2013
    Classification Date
    June 30, 2014
    Termination Date
    June 30, 2014
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.

    Reason

    the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.

    Code Info

    Lot Numbers: GD894535, GD894550

    Distribution

    Distributed in the states of AR, TN MO, KS, TX, MS, and AL.

    Quantity

    20,940 units