Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 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 April 29, 2011).
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- March 24, 2011
- Posted
- April 29, 2011
- Terminated
- April 29, 2011
- Recall Number
- Z-2122-2011
- Quantity
- 3 units
- Firm Location
- Round Lake, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Pumps submitted for service may not have been properly serviced before being returned to the customer.
Distribution
Puerto Rico
Lot / Code Info
Serial numbers 6100410FA, 8110687FA and 11021746FA
Root Cause
Employee error
Action Taken
Baxter visited the direct accounts starting on 3/24/11 informing them that the affected Flo-Gard pumps may have been released from the preventative maintenance with incorrect accuracy testing. The affected pumps were located, taken out of service and placed in quarantine on the same date. A technician not involved with the previous testing visited both accounts on 3/25/11 and performed preventative maintenance service of the three affected devices, and were found to be within specification.