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Novalung sensor box is a component of the Novalung Console… recallZ-1822-2024 · Fresenius Medical Care Holdings, Inc. · initiated Apr 8, 2024

Class II Open, Classified All recalls posted in May 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1822-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 8, 2024
Posted by the FDA
May 15, 2024
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
88 units
Product code
QJZ
FDA submissions
K191407
Distribution
US Nationwide distribution.

Product description

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 (models, lots, serial numbers)

UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124

Other devices under the same FDA submission

2 devices cleared under K191407 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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