BEUDAMED
    FDA Recall Terminated

    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.

    Recall: Z-0607-2016 · Initiated November 30, 2015

    Recall

    Recall Number
    Z-0607-2016
    Event Number
    72787
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 30, 2015
    Terminated
    October 30, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.

    Reason

    Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

    Action

    Baxter sent an Urgent Product Recall letter by letter on 11/30/2015 to affected customers. The recall was extended to the consumer/user level. The letter instructed customers to locate and remove all affected product, contact Baxter Healthcare Center for Service to arrange for return of affected products and credit and complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email.

    Distribution

    US Nationwide Distribution and the country of Canada

    Quantity

    77,136 units