NX19 West Sub-Assembly-Japan Only, Export Only
2 catalogue numbers from CXOT281, listed by Terumo Cardiovascular Systems Corporation, United States, under Oxygenator, Cardiopulmonary Bypass. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
12510(k) clearances naming this product code
22recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180950 |
| Record published | 2021-03-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | 4 piece case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CXOT281 | In distribution | |
| CXOT281 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180950 | 2018-06-22 |
| K172071 | 2018-03-29 |
| K153213 | 2015-12-03 |
| K153140 | 2015-12-02 |
| K151791 | 2015-11-19 |
| K151389 | 2015-10-20 |
| K140774 | 2014-06-02 |
| K130333 | 2013-03-13 |
| K130359 | 2013-03-13 |
| K062381 | 2006-08-24 |
| K051997 | 2005-09-15 |
| K010443 | 2001-12-11 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2023-03-01 | Class II | Process control | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator | 84 units | |
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 16 units | 2020-06-11 |
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 52units | 2020-06-11 |
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 78 units | 2020-06-11 |
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 123 units | 2020-06-11 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-03-01 | Class II | Process control | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator | 1412 units | |
| 2023-03-01 | Class II | Process control | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator | 4940 units | |
| 2020-11-11 | Class II | Labeling mix-ups | Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) | 5,079 Total: 523 US and 4,556 OUS | 2021-11-22 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 10 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 22 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 3 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 37 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 30 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 2013-01-23 | |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 13 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 160 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 7 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 215 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 3 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 173 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 170 units | 2013-01-23 |
| 2010-06-28 | Not classified | Employee error | Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators. | 16 units | 2012-02-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.