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.
What this means for you
Illness, injury, or structural failure has been reported. 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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