Novalung sensor box is a component of the Novalung recall
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that…
Why was Novalung sensor box is a component of the Novalung 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124
- Product
- Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 88 units
- Distribution
- US Nationwide distribution.
- Recall date
- May 22, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)