Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor
Terumo is recalling 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving medical devices where functional failure could impact patient care.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 123 units of the Capiox NX19 Oxygenator (West Orientation, P/N: CXOT281). The recall is due to the possibility that the devices may contain a non-functioning arterial thermistor component.
The affected units were exported only to Japan for inclusion into convenience kits sold within the Japanese market. The distribution pattern is listed as Foreign: Japan, Belgium. The specific lot numbers involved are XA21, XA29, XC04, XC18, XD05, and XD27.
This is a Class II recall. Users should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the affected devices.
The recalled product
- Product
- Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 123
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 (6)
- Lot Numbers: XA21
- XA29
- XC04
- XC18
- XD05
- XD27
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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