Mc3 Inc: 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: 4

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

Details from the source

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: US Nationwide distribution. Quantity: 188 units Lot/code info: GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039

UPC codes

10854916006871, 10854916006895

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.