NautilusTM Smart ECMO Module with Balance recall
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and…
Why was NautilusTM Smart ECMO Module with Balance recalled?
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer
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?
GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039
- Product
- NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and…
- Recalling firm
- Mc3 Inc
- Quantity
- 188 units
- Distribution
- US Nationwide distribution.
- Recall date
- March 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)