BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.

    Recall: Z-1565-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1565-2013
    Event ID
    65254
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 21, 2013
    Classification Date
    June 21, 2013
    Termination Date
    July 14, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.

    Reason

    leaking pouches

    Code Info

    Lot Number GD893891

    Distribution

    Nationwide Distribution.

    Quantity

    629,280 units