BEUDAMED
    FDA Recall Terminated

    Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock, Extension Set, 39" (99 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, Extension Set, 8" (20 cm), Vol. 1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0142 Intended use: for the administration of sterile I.V. fluids to the patient

    Recall: Z-0480-2012 · Initiated December 6, 2011

    Recall

    Recall Number
    Z-0480-2012
    Event Number
    60608
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FMG
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 6, 2011
    Posted
    January 11, 2012
    Terminated
    November 1, 2012
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock, Extension Set, 39" (99 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, Extension Set, 8" (20 cm), Vol. 1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0142 Intended use: for the administration of sterile I.V. fluids to the patient

    Reason

    During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.

    Action

    The firm, Baxter, sent an "Urgent Product Recall" letter dated December 6, 2011, via first class mail to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect all locations where their facility's inventory is located for products with the affected lot numbers; return the affected product; request a credit or replacement by calling Baxter Healthcare Center for Service at 1-888-229-0001 between 7:00am to 6:00pm Central time, Monday through Friday; complete and return the attached Customer Reply Form via fax to: 1-847-270-5457, or scan and email to [email protected]; and if they are a dealer, wholesaler, or distributor/reseller that distributed any affected product to other facilities, please notify their customers of this recall. If you have any questions regarding the communication, please 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 states of: Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Washington, Wisconsin and West Virginia; and country of: New Zealand.

    Quantity

    2,832 units