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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Baxter Flo-Gard 6201 Volumetric Infusion Pumps		see related information
Date Posted April 29, 2011
Recall Number Z-2122-2011
Product Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
Code Information Serial numbers 6100410FA, 8110687FA and 11021746FA
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 Pumps submitted for service may not have been properly serviced before being returned to the customer.
Action Baxter visited the direct accounts starting on 3/24/11 informing them that the affected Flo-Gard pumps may have been released from the preventative maintenance with incorrect accuracy testing. The affected pumps were located, taken out of service and placed in quarantine on the same date. A technician not involved with the previous testing visited both accounts on 3/25/11 and performed preventative maintenance service of the three affected devices, and were found to be within specification.
Quantity in Commerce 3 units
Distribution Puerto Rico
 
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