FDAFDA · Food and drugs·Recall number Z-1309-2024
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
Published March 27, 2024 · Recall initiated: October 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mc3 Inc
- Distributor
- US Nationwide distribution.
- Lot
- GTIN: (1) 10854916006888; (2) 10854916006901,20854916006908 (New GTIN (USA only)After reboxing). All Serial Numbers between 481022923 and 481024039
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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