Reported Mar 27, 2024 · Ongoing
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood,…
Mc3 Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mc3 Inc · 2555 Bishop Cir W · Dexter, MI · 48130-1563
Is this the product you have?
- NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature
- Product Number
4813548135E
- Lot codes and dates
- GTIN(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039
- Amount recalled
- 188 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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