Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-...
FDA Device Recall #Z-0562-2022 — Class II — December 7, 2021
Recall Summary
| Recall Number | Z-0562-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 7, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fresenius Medical Care Holdings, Inc. |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 115 units |
Product Description
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 Pattern
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV.
Lot / Code Information
Serial Numbers: XCONUS0013 XCONUS0079 XCONUS0105 XCONUS0036 XCONUS0044 XCONUS0004 XCONUS0014 XCONUS0080 XCONUS0109 XCONUS0021 XCONUS0066 XCONUS0027 XCONUS0017 XCONUS0084 XCONUS0061 XCONUS0043 XCONUS0089 XCONUS0059 XCONUS0019 XCONUS0085 XCONUS0051 XCONUS0047 XCONUS0005 XCONUS0042 XCONUS0020 XCONUS0086 XCONUS0110 XCONUS0055 XCONUS0010 XCONUS0083 XCONUS0022 XCONUS0087 XCONUS0111 XCONUS0064 XCONUS0053 XCONUS0121 XCONUS0023 XCONUS0088 XCONUS0112 XCONUS0002 XCONUS0056 XCONUS0018 XCONUS0024 XCONUS0090 XCONUS0113 XCONUS0003 XCONUS0006 XCONUS0054 XCONUS0030 XCONUS0091 XCONUS0115 XCONUS0007 XCONUS0052 XCONUS0081 XCONUS0032 XCONUS0094 XCONUS0116 XCONUS0012 XCONUS0073 XCONUS0008 XCONUS0039 XCONUS0095 XCONUS0118 XCONUS0070 XCONUS0009 XCONUS0040 XCONUS0096 XCONUS0025 XCONUS0072 XCONUS0001 XCONUS0049 XCONUS0092 XCONUS0026 XCONUS0075 XCONUS0011 XCONUS0058 XCONUS0093 XCONUS0028 XCONUS0082 XCONUS0045 XCONUS0067 XCONUS0097 XCONUS0122 XCONUS0048 XCONUS0065 XCONUS0068 XCONUS0098 XCONUS0123 XCONUS0063 XCONUS0029 XCONUS0069 XCONUS0099 XCONUS0124 XCONUS0031 XCONUS0035 XCONUS0074 XCONUS0100 XCONUS0034 XCONUS0071 XCONUS0046 XCONUS0076 XCONUS0102 XCONUS0038 XCONUS0060 XCONUS0050 XCONUS0077 XCONUS0103 XCONUS0041 XCONUS0062 XCONUS0015 XCONUS0078 XCONUS0104 XCONUS0033 XCONUS0037 XCONUS0016 UDI: Prefix: 4057224 (+ serial number)
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.