BEUDAMED
    FDA Recall Terminated

    Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 97'' long, 10 drops per mL plus Standard Bore 4-way Stopcock Extension Set, 35'' long, 5.2 mL volume, Male Luer Lock Adapter; Baxter Healthcare Corporation, Deerfield, IL 60015

    Recall: Z-0453-03 · Initiated December 18, 2002

    Recall

    Recall Number
    Z-0453-03
    Event Number
    25247
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    KSB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2002
    Posted
    January 16, 2003
    Terminated
    September 30, 2003
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 97'' long, 10 drops per mL plus Standard Bore 4-way Stopcock Extension Set, 35'' long, 5.2 mL volume, Male Luer Lock Adapter; Baxter Healthcare Corporation, Deerfield, IL 60015

    Reason

    Leakage may occur at the inlet port

    Action

    The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.

    Distribution

    Nationwide

    Quantity

    6,724