BEUDAMED
    FDA Recall Terminated

    Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375 Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

    Recall: Z-2837-2011 · Initiated July 6, 2011

    Recall

    Recall Number
    Z-2837-2011
    Event Number
    59263
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 6, 2011
    Posted
    July 15, 2011
    Terminated
    April 18, 2012
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375 Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

    Reason

    Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

    Action

    The firm, Baxter, sent an "Urgent Product Recall" letter dated July 6, 2011 via first class mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from their facility; call Baxter Healthcare's Center for Service at 1-888-229-0001 between 7:00 am and 6:00 pm Central Time, Monday through Friday to return affected product and receive credit; complete and return the attached CUSTOMER REPLY FORM to Baxter via fax at 1-847-270-5457 or scan and email to [email protected] and if you are a dealer, wholesaler or distributor/reseller, notify your customers of this recall. If you have questions regarding the communication, call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

    Distribution

    Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.

    Quantity

    9,800 sets