FDAOctober 11, 2023device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
mc3
UPCs
108549160068881085491600690120854916006908
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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