Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor
Terumo is recalling 52 Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (non-functioning thermistor) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 52 units of the Capiox NX19 Oxygenator With Reservoir (West Orientation), P/N: 3CX*NX19RW. The recall is due to the possibility that the devices contain a non-functioning arterial thermistor component.
The affected units are identified by lot numbers XAl 1, XA28, and XC07. Distribution was limited to Michigan and foreign locations in Japan and Belgium.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact Terumo Cardiovascular Systems Corporation for further instructions on how to proceed.
The recalled product
- Product
- Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: XAl 1
- XA28
- XC07
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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