BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2074-2014 · Initiated June 17, 2014

    Recall

    Recall Number
    Z-2074-2014
    Event Number
    68590
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 17, 2014
    Posted
    July 17, 2014
    Terminated
    April 3, 2015
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

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

    Reason

    Inadequate iodine and packaging related defects.

    Action

    The firm notified their direct consignees on 06/17/2014 by letter requesting customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit.

    Distribution

    Distributed USA (nationwide) and Canada.

    Quantity

    585,360 units