Z-1310-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2024
- Initiation Date
- October 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188 units
Product 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 for Recall
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 Pattern
US Nationwide distribution.
Code Information
GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039