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.
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- November 17, 2010
- Posted
- January 21, 2011
- Terminated
- March 16, 2011
- Recall Number
- Z-0933-2011
- Quantity
- 1 pump
- Firm Location
- Round Lake, IL
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.
Distribution
Nationwide distribution: WA only
Lot / Code Info
product code 2M8063, serial number 11091330FA
Root Cause
Process control
Action Taken
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.