Fresenius Medical Care Holdings, Inc. Recall 94393
Description: Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
Fresenius Medical Care Holdings, Inc. Recall 94393 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1822-2024 |
| Event ID | 94393 |
| Event Description | Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 88 units |
| Recall Reason | Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system. |
| Device Classification | 20240522 |
| Device Code Info | UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124 |
| Center Classification Date | 20240515 |
| Recall Initiation Date | 20240408 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
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