Recall Z-0134-2012 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
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.
| Date | Oct 28, 2011 (initiated Aug 26, 2011) |
| Status | Terminated |
| Reason | The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 1 unit |
| Distribution | Distributed only in Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915523 | FLO-GARD(R) 6301 Baxter Healthcare Corp, Feb 28, 1992 |