Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor
Terumo is recalling 78 Capiox NX19 Oxygenators exported to Japan and Belgium because they may contain a non-functioning arterial thermistor component.
What this means for you
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 is classified as FDA Class II, and the hazard involves a non-functioning component in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 78 units of the Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280. 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, with distribution also noted for Belgium. The specific lot numbers involved are XA28, XC12, XC25, XD05, and XD27.
This recall is classified as Class II by the U.S. Food and Drug Administration. Healthcare providers and patients should check their inventory and device records for the listed lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 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
- 78
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 (5)
- Lot Numbers: XA28
- XC12
- XC25
- 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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