Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Arterial Thermistor
Terumo is recalling 16 Capiox NX19 Oxygenators with a non-functioning arterial thermistor component. The units were distributed in Michigan, Japan, and Belgium.
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 is classified as FDA Class II. The hazard involves a non-functioning component in a medical device, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 16 units of the Capiox NX19 Oxygenator With Reservoir (East Orientation), P/N: 3CX*NX19RE. The recall is due to a non-functioning arterial thermistor component.
The affected units, identified by Lot Number WP17, were distributed in Michigan, Japan, and Belgium. The source text does not specify the exact number of units distributed in each location or the specific dates of distribution.
Healthcare providers and facilities should stop using the affected oxygenators and contact Terumo Cardiovascular Systems Corporation for instructions on return or replacement. The source text does not provide specific contact details or a deadline for the recall.
The recalled product
- Product
- Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 16
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 (1)
- Lot Number: WP17
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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