BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.

    Recall: Z-2074-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2074-2014
    Event ID
    68590
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2014
    Initiation Date
    June 17, 2014
    Classification Date
    July 17, 2014
    Termination Date
    April 3, 2015
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.

    Reason

    Inadequate iodine and packaging related defects.

    Code Info

    GD895771

    Distribution

    Distributed USA (nationwide) and Canada.

    Quantity

    585,360 units