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.
Recall
- Recall Number
- Z-2122-2011
- Event Number
- 58482
- Firm
- Baxter Healthcare Corp. Rt.
- FEI Number
- 1416980
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 24, 2011
- Posted
- April 29, 2011
- Terminated
- April 29, 2011
- Address
- 120 & Wilson Rd, Round Lake, IL, 60073
Description
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.
Pumps submitted for service may not have been properly serviced before being returned to the customer.
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.
Puerto Rico
3 units