FDA Enforcement
Class II
Ongoing
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
Recall: Z-1310-2024
·
Reported March 27, 2024
Enforcement
- Recall Number
- Z-1310-2024
- Event ID
- 94016
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mc3 Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 27, 2024
- Initiation Date
- October 11, 2023
- Classification Date
- March 19, 2024
- Address
- 2555 Bishop Cir W, Dexter, MI, 48130-1563, United States
Description
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
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
Code Info
GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039
Distribution
US Nationwide distribution.
Quantity
188 units