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.
This recall has been terminated (originally issued October 28, 2011).
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- August 26, 2011
- Posted
- October 28, 2011
- Terminated
- October 31, 2011
- Recall Number
- Z-0134-2012
- Quantity
- 1 unit
- Firm Location
- Round Lake, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed only in Puerto Rico.
Lot / Code Info
product code 2M8064, serial number 8110057FB
Root Cause
Employee error
Action Taken
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.
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