Z-1822-2024Class II

Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours)...

Name: Z-1822-2024 Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours)...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2024-04-08
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2024-04-08 / Open, Classified / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides... on 2024-04-08. FDA classified it as Class II and gives the reason as "Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1822-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-08
Posted: 2024-05-15
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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 adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
Product code: QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Reason for recall: Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical issued Urgent Medical Device Correction Letter (FA-2021-33-C_REV B) on 4/8/24. Letter states reason for recall, health risk and action to take: If you experience either failure codes (#206/#208) your machine will continue to operate. The essential performance is not affected. It is therefore important to note that the adjusted pump speed will be maintained by the system. The intended use of the Novalung system is to provide respiratory and cardiopulmonary support by extracorporeal circulation and physiologic gas exchange is not impacted by the flow measurement error messages To correct this issue, FMCRTG will update the sensor box on your Novalung console. An FMCRTG Field Service Technician will be contacting you to schedule this correction. In the 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 console is available. Reference section 6.2 of the Instructions for Use (Part Number US-003-2019-08). For questions or concerns, please contact your local sales representative or FMCRTG Technical Support Services at 1-800-405-1321.
Quantity in commerce: 88 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1822-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-15

Product code QJZ

K191407Class IINovalung SystemFresenius Medical Care Renal Therapies Group, LLC / cleared 2020-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)