# FDA recall Z-0562-2022

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2021-12-07.

## 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,

## Reason for recall

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.

## Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR,  PA, TN, TX, WV.

## Key facts

- **Recall number:** Z-0562-2022
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-07
- **Report date:** 2022-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0562-2022

## Citation

> AI Analytics. FDA recall Z-0562-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0562-2022. Source: US FDA. Licensed CC0.

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