BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1945-2014 · Initiated July 8, 2013

    Recall

    Recall Number
    Z-1945-2014
    Event Number
    68640
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    July 8, 2013
    Posted
    June 30, 2014
    Terminated
    June 30, 2014
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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.

    Action

    An Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013.

    Distribution

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

    Quantity

    20,940 units