Recall Z-0562-2022 ยท QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Fresenius Medical Care Holdings, Inc.
Novalung Sensor Box (F30000163) a component of 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, where other available treatment options hav
| Date | Dec 7, 2021 |
| Status | Open, Classified |
| Reason | Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection. |
| Root cause | Under Investigation by firm |
| Action | Fresenius Medical Care issued Urgent Medical Device Correction Letter ( Novalung Sensor Box P/N F30000163 FA-2021-33-C) on 12/7/21 via USPS First Class Mail. Letter sates reason for recall, health risk and action to take: In the rare event 206/208 alarms occur, you may silence the alarms intermittently using the audio pause button. If you have continued alarms, it is recommended to replace either the sensor box or the entire console if a secondary or backup sensor box is available. Reference section 6.2 of the Instructions for Use (Part Number US (Part Number US-003-2019-08). If available, swi |
| Quantity | 115 units |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV. |
| 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 |