Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Reported: August 7, 2019 Initiated: June 14, 2019 #Z-2101-2019
Product Description
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Reason for Recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 16 units
- Distribution
- MI Foreign: Japan, Belgium
- Location
- Elkton, MD
Frequently Asked Questions
What product was recalled? ▼
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 16 units.
Why was this product recalled? ▼
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2101-2019.
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