Novalung Sensor Box Recalled for Flow Measurement Technical Failure
Fresenius is recalling 88 Novalung sensor boxes for error messages affecting flow measurement. The defect impacts measurement capabilities in a life-support system used for acute respiratory and cardiac failure patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. The sensor box is a component of a life-support system providing extracorporeal circulation and gas exchange for critically ill patients. The technical failure affects flow measurement, which is critical to safe device operation. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' as no patient injuries have been documented but the hazard presents potential for harm.
Plain-English summary
The Novalung sensor box is a component of the Novalung Console, an FDA Class II medical device used for long-term respiratory and cardiopulmonary support. The device provides assisted extracorporeal circulation and physiologic gas exchange for patients with acute respiratory or cardiac failure.
The sensor box displays error messages #206 (yellow) and #208 (red) during operation, indicating a technical failure that affects flow measurement. Fresenius Medical Care is recalling 88 units due to this issue.
A total of 88 units with UDI-DI 4057224 (serial numbers XCONUS0001 through XCONUS0124) have been distributed nationwide throughout the United States. Healthcare facilities should verify whether their equipment contains the affected serial numbers.
Contact your supplier or the FDA for guidance on remediation options for affected devices.
The recalled product
- Product
- 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 a
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- sensor-failure
- flow-measurement-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124
Distribution
Distributed nationwide across the United States.
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