Recall Z-2122-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
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.
| Date | Apr 29, 2011 (initiated Mar 24, 2011) |
| Status | Terminated |
| Reason | Pumps submitted for service may not have been properly serviced before being returned to the customer. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 3 units |
| Distribution | Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915522 | FLO-GARD(R) 6201 Baxter Healthcare Corp, Feb 28, 1992 |