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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 Device Recall Baxter FloGard 6201 Volumetric Infusion Pump see related information
Date Initiated by Firm November 17, 2010
Date Posted January 21, 2011
Recall Status1 Terminated 3 on March 16, 2011
Recall Number Z-0933-2011
Recall Event ID 57334
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 IL 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
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