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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 FloGard 6201 Volumetric Infusion Pump		see related information
Date Posted January 21, 2011
Recall Number Z-0933-2011
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
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.
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
 
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