B. Braun Medical, Inc. Recall 92978
Description: 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
B. Braun Medical, Inc. Recall 92978 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0123-2024 |
| Event ID | 92978 |
| Event Description | 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada. |
| Quantity | 9771 |
| Recall Reason | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death. |
| Device Classification | 20231101 |
| Device Code Info | UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 |
| Center Classification Date | 20231025 |
| Recall Initiation Date | 20230921 |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
| Similar To |