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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter FloGard 6301 Volumetric Infusion Pump

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 Class 2 Recall
Baxter FloGard 6301 Volumetric Infusion Pump
see related information
Date Posted October 28, 2011
Recall Status1 Terminated on October 31, 2011
Recall Number Z-0134-2012
Recall Event ID 60168
Premarket Notification
510(K) Number
K915523 
Product Classification Pump, Infusion - Product Code FRN
Product Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
Code Information product code 2M8064, serial number 8110057FB
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.
FDA Determined
Cause 2
TRAINING: Employee Error
Action A Baxter Healthcare technician initially notified the sole customer on August 26, 2011 of the defective product and requested that the product be quarantined. On September 14, 2011 a technician visited the site to correct the problem observed on the Flo-Gard Infusion Pump. All required tests were performed and the results were found acceptable.
Quantity in Commerce 1 unit
Distribution Distributed only in 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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