BEUDAMED
    FDA Recall Terminated

    Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1'', Total Volume 0.75 mL, Total Length 10''; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    Recall: Z-1437-05 · Initiated August 3, 2005

    Recall

    Recall Number
    Z-1437-05
    Event Number
    32812
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 3, 2005
    Posted
    August 30, 2005
    Terminated
    August 18, 2008
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1'', Total Volume 0.75 mL, Total Length 10''; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    Reason

    The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

    Action

    Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.

    Distribution

    Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.

    Quantity

    5,326 sets