Class II — Fresenius Medical Care Holdings, Inc.
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | 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 have failed, |
| 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. |
| Initiated | 2021-12-07 |
| Classified | 2022-02-04 |
| Recall number | Z-0562-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Fresenius Medical Care Holdings, Inc. (Z-0562-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89369/
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