Recall Z-1822-2024 ยท QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Fresenius Medical Care Holdings, Inc.
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
| Date | May 15, 2024 (initiated Apr 8, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Fresenius Medical issued Urgent Medical Device Correction Letter (FA-2021-33-C_REV B) on 4/8/24. Letter states reason for recall, health risk and action to take: If you experience either failure codes (#206/#208) your machine will continue to operate. The essential performance is not affected. It is therefore important to note that the adjusted pump speed will be maintained by the system. The intended use of the Novalung system is to provide respiratory and cardiopulmonary support by extracorporeal circulation and physiologic gas exchange is not impacted by the flow measurement error messages |
| Quantity | 88 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191407 | Novalung System Fresenius Medical Care Renal Therapies Group, LLC, Feb 21, 2020 |