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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter FloGard 6201 Volumetric Infusion Pump

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 Class 2 Recall
Baxter FloGard 6201 Volumetric Infusion Pump
see related information
Date Posted January 21, 2011
Recall Status1 Terminated on March 16, 2011
Recall Number Z-0933-2011
Recall Event ID 57334
Premarket Notification
510(K) Number
K915522 
Product Classification Pump, Infusion - Product Code FRN
Product Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063 For delivery of intravenous solutions, drug solutions, enteral feedings and blood.
Code Information product code 2M8063, serial number 11091330FA
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 FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm, Baxter, telephoned the one customer on November 17, 2010, informing them that electrical safety testing was not performed on their FloGard pump serial number 11091330FA during the last service. Since the test was not conducted on the pump, the device may not function as designed and could lead to a hazard of electrical shock. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter advised the customer that a Baxter Field Service Engineer would be sent to their facility to perform electrical safety testing or alternatively, the customer may choose to send the pump to Baxter for testing. If you have any questions regarding this information, please contact Vice President, Quality, GIS at 847-270-5507.
Quantity in Commerce 1 pump
Distribution Nationwide distribution: WA only
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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