—#38825

Product

Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G (global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B; Baxter Healthcare Corporation, Deerfield, IL 60015

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915522
Affected lot / code info: all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

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

Timeline

Recall initiated: 2005-05-03
Posted by FDA: 2005-09-21
Terminated: 2008-03-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38825. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.