BEUDAMED
    FDA Recall Terminated

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    Recall: Z-0194-2016 · Initiated October 6, 2015

    Recall

    Recall Number
    Z-0194-2016
    Event Number
    72362
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    KDJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 6, 2015
    Terminated
    June 27, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    Reason

    Leakage from the inlet port of the 15L Cycler Drainage Bags.

    Action

    Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.

    Distribution

    US Distribution and Internationally to Canada.

    Quantity

    19,440 units