BEUDAMED
    FDA Recall Terminated

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL 60015

    Recall: Z-1553-05 · Initiated May 3, 2005

    Recall

    Recall Number
    Z-1553-05
    Event Number
    31965
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 3, 2005
    Posted
    September 21, 2005
    Terminated
    March 4, 2008
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL 60015

    Reason

    The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.

    Action

    Safety Alert letters dated 5/3/05 were sent to all Flo-Gard 6201 and 6301 Volumetric Infusion Pump customers. The letters informed the users of the potential for the pole clamp mounting screws to come loose, and recommended that they inspect the Flo-Gard pole clamp during their routine maintenance or as part of the recommended annual preventative cycle. If the pole clamp appears to be loose, the users were provided with the following steps to be followed to ensure that the pole clamp is properly secured: a) The recessed area in the housing for the clamp body must be clean. b) The three mounting screw holes in the housing must not show signs of cracking. c) The ground wire must be attached to the center screw. d) The screws must be M4x10 with captive washer. e) Loctite 425 threadlocker must be applied to each of the three screws. f) Torque the screws to 7.8 in-lb. Enclosed was a copy of the Service Bulletin issued in April 2002 with additional information about servicing the Flo-Gard pole clamps.

    Distribution

    Nationwide including Puerto Rico, and internationally to Canada, Taiwan, Thailand, Belgium, Switzerland, New Zealand, China, Argentina, Peru, Australia, Asia, Hong Kong and the Philippines.

    Quantity

    61,759 units