Plegiox Cardioplegia Heat Exchanger
PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions…
PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature-controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
1manufacturer
1catalogue number
13510(k) clearances naming this product 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 | Maquet Cardiopulmonary GmbH, Germany |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K112360 |
| Record published | 2017-03-13 |
| Record revised | 2024-09-30 (version 5) |
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, manufacturing date |
| Packaging | Pack of 8 |
| Distribution end date | 2024-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BO-CHX 30, SOFTLINE, Sterile | Withdrawn |
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 |
|---|---|
| K150267 | 2015-05-07 |
| K132829 | 2013-10-08 |
| K112360 | 2011-09-15 |
| K103191 | 2011-03-08 |
| K102464 | 2011-03-04 |
| K101153 | 2010-12-08 |
| K100278 | 2010-04-30 |
| K093522 | 2009-12-07 |
| K090689 | 2009-10-29 |
| K090511 | 2009-06-12 |
| K082117 | 2009-02-18 |
| K071774 | 2008-01-23 |
| K061628 | 2006-08-22 |
Recalls Naming This Product
12 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 |
|---|---|---|---|---|---|---|---|
| Maquet Medical Systems, Usa | 510(k) number | 2024-01-16 | Class II | Nonconforming Material/Component | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. | 16520 worldwide; 6657 US | |
| Maquet Medical Systems, Usa | 510(k) number | 2024-01-16 | Class II | Nonconforming Material/Component | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. | 16520 worldwide; 6657 US | |
| Maquet Medical Systems, Usa | 510(k) number | 2023-02-13 | Class II | Process control | Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia. | 10,587 units (US); 94,987 (worldwide) | |
| Maquet Medical Systems, Usa | 510(k) number | 2022-07-22 | Class II | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). | 206 US; 48,960 Worldwide | |
| Maquet Medical Systems, Usa | 510(k) number | 2022-07-22 | Class II | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). | 206 US; 48,960 Worldwide | |
| Maquet Medical Systems, Usa | 510(k) number | 2022-07-22 | Class II | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). | 6,871 US; 18,670 worldwide | |
| Maquet Medical Systems, Usa | 510(k) number | 2022-07-22 | Class II | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). | 6,871 US; 18,670 worldwide | |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2020-11-20 | Class II | Package design/selection | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product’s sterility barrier. | 58,438 devices worldwide | 2024-11-07 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2020-11-20 | Class II | Package design/selection | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product’s sterility barrier. | 2024-11-07 | |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-07-11 | Class II | Under Investigation by firm | The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly | 54 | 2020-12-11 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2013-08-15 | Class II | Nonconforming Material/Component | The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet con | 1,182 units | 2017-07-11 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2012-06-12 | Class II | Nonconforming Material/Component | It has come to firm’s attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped. | 23,203 units | 2017-09-29 |
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.