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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter FloGard 6201 Volumetric Infusion Pumps

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 Class 2 Recall
Baxter FloGard 6201 Volumetric Infusion Pumps
see related information
Date Posted April 29, 2011
Recall Status1 Terminated on April 29, 2011
Recall Number Z-2122-2011
Recall Event ID 58482
Premarket Notification
510(K) Number
K915522 
Product Classification Pump, Infusion - Product Code FRN
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
Manufacturer Reason
for Recall
Pumps submitted for service may not have been properly serviced before being returned to the customer.
FDA Determined
Cause 2
TRAINING: Employee Error
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
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