Recall Z-0933-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063 For delivery of intravenous solutions, drug solutions, enteral feedings and blood.
| Date | Jan 21, 2011 (initiated Nov 17, 2010) |
| Status | Terminated |
| Reason | The FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock. |
| Root cause | Process control |
| Action | The firm, Baxter, telephoned the one customer on November 17, 2010, informing them that electrical safety testing was not performed on their FloGard pump serial number 11091330FA during the last service. Since the test was not conducted on the pump, the device may not function as designed and could lead to a hazard of electrical shock. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter advised the customer that a Baxter Field Service Engineer would be sent to their facility to perform electrical safety testing or alternatively, the customer may ch |
| Quantity | 1 pump |
| Distribution | Nationwide distribution: WA only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915522 | FLO-GARD(R) 6201 Baxter Healthcare Corp, Feb 28, 1992 |