FDAClass IIAugust 7, 2019

Terumo Capiox NX19 Oxygenator With Reservoir recall

Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

Why was Terumo Capiox NX19 Oxygenator With Reservoir recalled?

Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: WP17

Product
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
16 units
Distribution
MI Foreign: Japan, Belgium
Recall date
August 7, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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