BEUDAMED
    FDA Enforcement Class II Completed

    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

    Recall: Z-1269-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1269-2015
    Event ID
    70512
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2015
    Initiation Date
    January 22, 2015
    Classification Date
    March 13, 2015
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

    Reason

    Product may have separating or protruding sponges

    Code Info

    Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.

    Quantity

    4,391,520 units