NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedur...
FDA Recall #Z-1310-2024 — Class II — October 11, 2023
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
Recalling Firm
Mc3 Inc — Dexter, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
188 units
Distribution
US Nationwide distribution.
Code Information
GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated