BEUDAMED
    FDA Recall 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 · Initiated May 21, 2013

    Recall

    Recall Number
    Z-1565-2013
    Event Number
    65254
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    May 21, 2013
    Posted
    June 21, 2013
    Terminated
    July 14, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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

    Action

    The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837.

    Distribution

    Nationwide Distribution.

    Quantity

    629,280 units