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U.S. Department of Health and Human Services

Class 2 Device Recall Novalung

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  Class 2 Device Recall Novalung see related information
Date Initiated by Firm April 08, 2024
Date Posted May 15, 2024
Recall Status1 Open3, Classified
Recall Number Z-1822-2024
Recall Event ID 94393
510(K)Number K191407  
Product Classification Extracorporeal system for long-term respiratory / cardiopulmonary failure - Product Code QJZ
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
Code Information UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Technical Service
800-405-1321
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QJZ and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
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