Mc3 recalls Nautilus ECMO Oxygenators with Balance Biosurface due to potential heat exchange problems that could cause hypothermia during extracorporeal life support.
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
Mc3 is recalling Nautilus ECMO Oxygenators with Balance Biosurface that may have reduced heat exchange performance, risking hypothermia for patients. This affects oxygenators used in life support procedures where temperature regulation is critical.
The oxygenator may have increased water path restriction in the heat exchanger, reducing blood temperature regulation. This could lead to hypothermia if the device fails to transfer heat properly during use, especially during prolonged medical procedures.
Patients using extracorporeal life support systems with this specific oxygenator model are most at risk. Healthcare providers and hospitals that use these devices for critical care may also be affected.
Check for serial numbers between 481022923 and 481024039 on the device. The product includes model numbers 48145 and 48145E with specific GTINs listed in the recall notice.
Look for the serial number on the device, which should be between 481022923 and 481024039.
Reach out to Mc3 Inc for further guidance on the recall and potential remedies.
The recalled models are 48145 and 48145E with serial numbers between 481022923 and 481024039.
The recall states the potential harm includes hypothermia due to inadequate heat transfer, which is a serious medical risk.
Check the serial number on the device; if it falls between 481022923 and 481024039, it is affected.
We’ve drafted a message you can send Mc3 to request your refund or repair — edit it as you like.
Subject: Recall Z-1309-2024 — Mc3 Mc3 Hello, I own a Mc3 that is covered by recall Z-1309-2024 from Mc3. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
