Mc3 Inc recalls NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, r…

Recall date

October 11, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1309-2024

FDA classification

Class II

Brand / firm

Mc3 Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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