Terumo Cardiovascular Systems Corporation 2023-04-12 Health serious FDA
Health · FDA · Recall #FDA-Z-1346-2023
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE Recall
Issued April 12, 2023 · Terumo Cardiovascular Systems Corporation
In April 2023, Terumo Cardiovascular Systems Corporation recalled the CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Terumo Cardiovascular Systems Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Terumo Cardiovascular Systems Corporation
- Category
- Health
- Recall date
- April 12, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- Recall number
- FDA-Z-1346-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Terumo Cardiovascular Systems Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.