BEUDAMED
    FDA Recall Terminated

    Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.

    Recall: Z-0392-2014 · Initiated September 25, 2013

    Recall

    Recall Number
    Z-0392-2014
    Event Number
    66389
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 25, 2013
    Posted
    November 26, 2013
    Terminated
    July 22, 2014
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.

    Reason

    Incomplete foil seal on one lot of sterile product.

    Action

    Baxter Healthcare sent an Urgent Product Recall letter dated September 25, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected product from their facility, contact Baxter's Center for Service at 1-888-229-0001 to arrange for return and credit. Complete the attached Customer Reply Form and return it to Baxter by fax or email. Customers with questions were instructed to call 1-800-422-9837. For questions regarding this recall call 224-948-4770.

    Distribution

    Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.

    Quantity

    38,400 units