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U.S. Department of Health and Human Services

Class 2 Device Recall FloGard 6301 Dual Chamber Volumetric Infusion Pumps

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  Class 2 Device Recall FloGard 6301 Dual Chamber Volumetric Infusion Pumps see related information
Date Initiated by Firm May 03, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on March 04, 2008
Recall Number Z-1553-05
Recall Event ID 31965
510(K)Number K915522  
Product Classification Pump, Infusion - Product Code FRN
Product 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
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 61,759 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
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