BEUDAMED
    FDA Recall Terminated

    Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

    Recall: Z-0376-04 · Initiated December 17, 2003

    Recall

    Recall Number
    Z-0376-04
    Event Number
    28037
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    FRN--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 17, 2003
    Posted
    January 29, 2004
    Terminated
    November 28, 2006
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

    Reason

    Premature motor failure.

    Action

    Baxter sent letters dated 12/17/03 to all Baxter 6060 Multi-Therapy Infusion Pump accounts that received pumps manufactured with the affected motors or who had their pumps refurbished with affected motors. The letters included a list of affected pump serial numbers for each facility. The accounts were informed of the possible premature motor failure, and were requested to contact Baxter via fax to schedule a service call to correct the pumps.

    Distribution

    The product was distributed nationwide, and internationally to Sweden, Germany, the United Kingdom, Australia and Japan.

    Quantity

    188 units