FDA recall Z-1347-2023

Terumo Cardiovascular Systems Corporation · Class II · device

Product

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

Reason for recall

Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

Distribution

US Nationwide. Belgium, Canada, Costa Rica, Thailand.

Key facts

Status: Ongoing
Initiation date: 2023-03-01
Report date: 2023-04-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1347-2023