CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) recalled
Terumo Cardiovascular Systems is recalling Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation), distributed in Michigan. The recall was initiated on 14 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2101-2019
- FDA event ID
- 83240
- Recalling firm
- Terumo Cardiovascular Systems, Elkton, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jun 2019
- FDA classified
- 30 Jul 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Jun 2019 | Recall initiated by company | |
| 30 Jul 2019 | Classified by FDA | +46 days |
| 7 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Product as listed by the FDA
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Where it was distributed
MI Foreign: Japan, Belgium
Questions about this recall
Why was it recalled?
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Which lots are affected?
Lot Number: WP17
Where was it sold?
MI Foreign: Japan, Belgium
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 83240| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Terumo Capiox NX19 Oxygenator (West Orientation recalled | Terumo Cardiovascular Systems | Other | MI | |
| CLASS II | Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) recalled | Terumo Cardiovascular Systems | Other | MI | |
| CLASS II | Terumo Capiox NX19 Oxygenator (East Orientation) recalled | Terumo Cardiovascular Systems | Other | MI |
More recalls from Terumo Cardiovascular Systems
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|---|---|---|---|---|---|
| Device | CLASS II | CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems | Terumo Cardiovascular Systems | Labeling Errors | Nationwide |
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| Device | CLASS II | Capiox RX15 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Capiox FX25 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
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