The Recall Desk

FDA (Devices) recall action 94016

Mc3 Inc recalled 2 products on 2024-03-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-03-27
Critical
0
Units
487

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2024-03-27

    Nautilus ECMO Oxygenator recalled due to heat exchanger water path restriction

    Mc3 Inc recalls Nautilus ECMO Oxygenator units due to heat exchanger water path restriction that degrades temperature control performance. Inadequate heat transfer may lead to hypothermia risk.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-03-27

    ECMO heat exchanger module recalled due to water path restriction

    Mc3 Inc is recalling 188 Nautilus Smart ECMO modules nationwide due to potential water path restrictions in the heat exchanger that may cause inadequate heat transfer and risk of hypothermia during use.

    Product
    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
    Category
    Distribution
    0 states