Dexter, MI, United States
Mc3 Inc recalls
1 recall recorded since 2018, most recently on 11 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 October 2023
- Reason
- 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
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1309-2024, Z-1310-2024
- NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
- 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: 48135, 48135E
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.