Sarns™ Cardioplegia Set
Catalogue number 4459, listed by Terumo Cardiovascular Systems Corporation, United States, under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K922992 |
| Record published | 2015-10-02 |
| Record revised | 2021-10-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| 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 |
|---|---|---|
| 4459 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| DLP™ | Medtronic, Inc. | 804 |
| Bio-Medicus™ | Medtronic, Inc. | 223 |
| Pemco Inc | Pemco, Inc. | 137 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 135 |
| Venous cardiopulmonary bypass cannula | LivaNova USA, Inc. | 97 |
| Eopa™ | Medtronic, Inc. | 87 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 80 |
| Arterial cardiopulmonary bypass cannula | LivaNova USA, Inc. | 79 |
| MC2™ | Medtronic, Inc. | 66 |
| Select Series® | Medtronic, Inc. | 63 |
| Edwards Lifesciences Aortic Perfusion Cannula | Edwards Lifesciences Technology Sarl | 52 |
Showing 12 of 372. All products under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150536 | 2015-05-05 |
| K132811 | 2014-02-27 |
| K132451 | 2014-02-18 |
| K133151 | 2014-02-03 |
| K090878 | 2009-04-03 |
| K083301 | 2008-12-18 |
| K080034 | 2008-06-17 |
| K063618 | 2007-03-13 |
| K062597 | 2006-11-03 |
| K023056 | 2002-11-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, 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 | 2011-03-01 | Class II | Device Design | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line | Catalog: 16579 ; Catalog 6375: 3256 units | 2014-11-06 |
Recalls
40 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 |
|---|---|---|---|---|---|
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 135,340 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 6,720 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 7,190 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 14,380 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 132, 250 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 120 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 32,880 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 125 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 20 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 3,040 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 2,290 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 7,460 units | 2015-02-24 |
| 2014-05-23 | Class II | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | 34,470 units | 2015-02-24 |
| 2014-03-03 | Class II | Device Design | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | 2014-08-12 | |
| 2014-03-03 | Class II | Device Design | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | 2014-08-12 | |
| 2014-03-03 | Class II | Device Design | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | 2014-08-12 | |
| 2014-03-03 | Class II | Device Design | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | 2014-08-12 | |
| 2014-03-03 | Class II | Device Design | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | 2014-08-12 | |
| 2014-03-03 | Class II | Device Design | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | 2014-08-12 | |
| 2014-03-03 | Class II | Device Design | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | 2014-08-12 | |
| 2013-10-23 | Class II | Employee error | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns” Soft-Flow Aortic Cannulae and Sa | 70 units | 2014-07-18 |
| 2013-10-23 | Class II | Employee error | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns” Soft-Flow Aortic Cannulae and Sa | 40 units | 2014-07-18 |
| 2013-10-23 | Class II | Employee error | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns” Soft-Flow Aortic Cannulae and Sa | 90 units | 2014-07-18 |
| 2013-10-23 | Class II | Employee error | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns” Soft-Flow Aortic Cannulae and Sa | 30 units | 2014-07-18 |
| 2013-01-07 | Class II | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the | 6830 total all products | 2013-08-26 |
| 2013-01-07 | Class II | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the | 6830 total units for all products | 2013-08-26 |
| 2013-01-07 | Class II | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the | 6830 total all products | 2013-08-26 |
| 2013-01-07 | Class II | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the | 6830 total all products | 2013-08-26 |
| 2013-01-07 | Class II | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the | 6830 total all products | 2013-08-26 |
| 2013-01-07 | Class II | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the | 6830 total all products | 2013-08-26 |
| 2012-11-21 | Class II | Process design | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been | 5760 total products | 2013-04-23 |
| 2012-11-21 | Class II | Process design | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been | 5760 total | 2013-04-23 |
| 2012-11-21 | Class II | Process design | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been | 5760 total | 2013-04-23 |
| 2012-11-21 | Class II | Process design | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been | 5760 total | 2013-04-23 |
| 2012-11-21 | Class II | Process design | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been | 5760 total units | 2013-04-23 |
| 2012-11-21 | Class II | Process design | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been | 5760 total | 2013-04-23 |
| 2012-11-21 | Class II | Process design | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been | 5760 total | 2013-04-23 |
| 2012-05-09 | Class II | Nonconforming Material/Component | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS’ preliminary investigation found that | 133,793 (each) | 2013-07-11 |
| 2012-05-09 | Class II | Material/Component Contamination | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS’ preliminary investigation found | 53,139 (each) in total | 2013-04-24 |
| 2012-05-09 | Class II | Material/Component Contamination | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS’ preliminary investigation found | 53,139 (each) in total | 2013-04-24 |
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.