Clearlink
The FDA filing describes the Clearlink Luer Activated Valve as an in-line access site that connects with male luer adapters, including syringes or sets, to provide needleless access to a…
The FDA filing describes the Clearlink Luer Activated Valve as an in-line access site that connects with male luer adapters, including syringes or sets, to provide needleless access to a fluid or vascular path.
When incorporated into an IV administration set, the valve is part of a pathway for delivering fluid from a container to a patient’s vascular system through a needle or catheter in a vein.
Listed Item
Non-DEHP Catheter Extension Set Kit, 1 Catheter Extension Set, Luer Activated Valve for IV Access, Male Luer Lock Adapter with Retractable Collar, 1 Medium Catheter Stabilization Device, 2 Foam Tape Strips
Access Site Function
The filing also identifies a Clearlink valve Y-site port for administration of secondary medication.
49manufacturers in China registered for this device type
34catalogue numbers in this listing
67510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112893 |
| Record published | 2016-09-24 |
| Record revised | 2021-03-08 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 48, case of 50, case of 200, pack of 50, case of 4 |
| Distribution end date | 2029-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2N8378 | In distribution | |
| 2C8858 | In distribution | |
| 2H8631 | In distribution | |
| 2C8606 | In distribution | |
| 2C8857 | In distribution | |
| 2R8403 | In distribution | |
| 2C8671 | In distribution | |
| 2C8425 | In distribution | |
| 2N8371 | In distribution | |
| 2N8374 | In distribution | |
| 2N8377 | In distribution | |
| 2N8220 | In distribution | |
| 2C8634 | In distribution | |
| 2C7461 | In distribution | |
| 2C8612 | In distribution | |
| 2R8486 | In distribution | |
| 1C8693 | In distribution | |
| 2C8401 | In distribution | |
| 2N8334 | In distribution | |
| 2R8858 | In distribution | |
| 2H8603 | In distribution | |
| 2R8401 | In distribution | |
| 2H8490 | In distribution | |
| 1C8687 | In distribution | |
| 2C8632 | In distribution | |
| 2N8399 | In distribution | |
| 2H8401 | In distribution | |
| 2N8341 | In distribution | |
| 2H8486 | In distribution | |
| 2C8607 | In distribution | |
| 2C8402 | In distribution | |
| 2C8610 | In distribution | |
| 2H8671 | In distribution | |
| 2N8222 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243529 | 2025-03-14 |
| K242339 | 2025-02-28 |
| K212262 | 2022-10-03 |
| K203609 | 2021-09-30 |
| K210430 | 2021-06-18 |
| K192366 | 2020-07-20 |
| K180739 | 2019-05-28 |
| K172544 | 2017-09-22 |
| K161808 | 2017-06-21 |
| K160007 | 2016-12-19 |
| K161323 | 2016-11-30 |
| K153158 | 2015-12-28 |
| K150860 | 2015-04-16 |
| K142011 | 2014-08-18 |
| K132734 | 2013-10-08 |
| K123874 | 2013-01-10 |
| K123868 | 2013-01-08 |
| K121634 | 2012-06-29 |
| K121092 | 2012-06-29 |
| K112893 | 2011-10-18 |
| K103551 | 2011-03-25 |
| K101385 | 2010-06-22 |
| K081289 | 2008-08-04 |
| K072576 | 2007-11-06 |
| K060074 | 2006-03-29 |
| K042936 | 2004-11-26 |
| K003225 | 2000-10-19 |
| K984060 | 1999-07-26 |
| K984381 | 1999-02-19 |
| K982672 | 1998-09-04 |
| K981792 | 1998-08-17 |
| K974571 | 1998-05-21 |
| K981318 | 1998-04-22 |
| K971701 | 1997-06-06 |
| K970438 | 1997-04-02 |
| K964850 | 1997-02-25 |
| K962893 | 1996-10-18 |
| K961495 | 1996-06-26 |
| K961225 | 1996-06-21 |
| K952074 | 1995-07-27 |
| K940867 | 1994-05-05 |
| K925362 | 1993-08-28 |
| K924721 | 1993-07-20 |
| K925126 | 1993-06-18 |
| K921899 | 1993-04-20 |
| K922558 | 1992-10-19 |
| K921703 | 1992-06-04 |
| K915828 | 1992-05-15 |
| K920694 | 1992-03-23 |
| K915390 | 1992-03-12 |
| K914048 | 1991-11-27 |
| K914074 | 1991-10-21 |
| K913627 | 1991-09-23 |
| K912141 | 1991-09-11 |
| K911868 | 1991-06-24 |
| K900909 | 1990-05-18 |
| K893646 | 1989-12-06 |
| K893716 | 1989-09-18 |
| K890489 | 1989-06-08 |
| K883638 | 1988-09-23 |
| K882007 | 1988-06-20 |
| K881321 | 1988-06-16 |
| K881052 | 1988-05-26 |
| K880482 | 1988-03-18 |
| K813194 | 1981-12-02 |
| K811463 | 1981-06-12 |
| K781036 | 1978-08-10 |
Recalls Naming This Product
28 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 510(k) number | 2025-08-29 | Class II | Process control | IV sets may leak. | 49200 | |
| Baxter Healthcare Corporation | UDI-DI | 2025-08-29 | Class II | Process control | IV sets may leak. | 1440 | |
| Baxter Healthcare Corporation | UDI-DI | 2025-08-29 | Class II | Process control | IV sets may leak. | 15552 | |
| Baxter Healthcare Corporation | UDI-DI | 2025-08-29 | Class II | Process control | IV sets may leak. | 2304 | |
| Baxter Healthcare Corporation | UDI-DI | 2025-08-29 | Class II | Process control | IV sets may leak. | 16416 | |
| Baxter Healthcare Corporation | UDI-DI | 2025-08-29 | Class II | Process control | IV sets may leak. | 69936 | |
| Baxter Healthcare Corporation | UDI-DI | 2025-08-29 | Class II | Process control | IV sets may leak. | 27072 | |
| Baxter Healthcare Corporation | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation. | 14400 units | |
| Baxter Healthcare Corporation | 510(k) number | 2024-12-20 | Class II | Process control | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. | ||
| Baxter Healthcare Corporation | 510(k) number | 2024-12-20 | Class II | Process control | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. | ||
| Baxter Healthcare Corporation | 510(k) number | 2024-12-20 | Class II | Process control | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. | ||
| Baxter Healthcare Corporation | 510(k) number | 2024-02-08 | Class II | Under Investigation by firm | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber. | 26,592 units | |
| Baxter Healthcare Corporation | 510(k) number | 2022-08-09 | Class I | Process design | Firm noted an increase in customer reports of leaks. | 511,728 units | 2024-08-09 |
| Baxter Healthcare Corporation | 510(k) number | 2019-12-12 | Class II | Device Design | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. | 271,014,984 units | |
| Baxter Healthcare Corporation | 510(k) number | 2019-12-12 | Class II | Device Design | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. | 43,495,400 units | |
| Baxter Healthcare Corporation | 510(k) number | 2013-09-04 | Class II | Under Investigation by firm | The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination. | 3,200 units | 2017-04-19 |
| Baxter Healthcare Corporation | 510(k) number | 2013-03-28 | Class II | Packaging process control | Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. | A) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222 | 2017-07-31 |
| Baxter Healthcare Corporation | 510(k) number | 2013-03-28 | Class II | Packaging process control | Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. | A) Product Code 2N8371: 513,000 units | 2017-07-31 |
| Baxter Healthcare Corporation | 510(k) number | 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 4,560 units | 2012-11-01 |
| Baxter Healthcare Corporation | 510(k) number | 2011-07-21 | Not classified | Employee error | The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded i | 4,752 units | 2012-06-18 |
| Baxter Healthcare Corporation | 510(k) number | 2010-09-09 | Not classified | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. | 108,000 sets | 2011-09-07 |
| Baxter Healthcare Corporation | 510(k) number | 2007-02-16 | Not classified | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. | 480 units | 2008-03-17 |
| Baxter Healthcare Corporation | 510(k) number | 2007-02-16 | Not classified | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. | 15,097 units | 2008-03-17 |
| Baxter Healthcare Corporation | 510(k) number | 2007-02-16 | Not classified | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. | 200,309 units | 2008-03-17 |
| Baxter Healthcare Corporation | 510(k) number | 2005-02-28 | Not classified | Other | Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve. | 1,171,116 sets | 2007-02-08 |
| Baxter Healthcare Corporation | 510(k) number | 2004-04-28 | Not classified | Other | Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device. | 29,425,708 sets | 2007-02-08 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 3,456 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 11,280 units | 2004-06-29 |
Recalls
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2026-06-30 | Class I | Under Investigation by firm | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. | 24528 units | |
| 2020-12-21 | Class II | Process design | There were customer reports of separation between the tubing and Male Luer Lock Adaptor. | 66,800 units | 2024-07-11 |
| 2015-11-30 | Class II | Under Investigation by firm | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. | 9600 units | 2016-10-30 |
| 2015-11-30 | Class II | Under Investigation by firm | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. | 9264 units | 2016-10-30 |
| 2015-05-21 | Class II | Packaging | Potential for a leak at the tubing to luer bond. | 23,600 | 2017-05-10 |
| 2014-07-14 | Class II | Nonconforming Material/Component | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, | 234196 | 2016-03-15 |
| 2014-07-14 | Class II | Nonconforming Material/Component | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, | 11184 | 2016-03-15 |
| 2014-07-14 | Class II | Nonconforming Material/Component | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, | 107232 | 2016-03-15 |
| 2013-08-30 | Class II | Packaging | Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 | 49,344 units | 2017-04-19 |
| 2013-03-28 | Class II | Packaging process control | Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. | A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101, | 2017-07-31 |
| 2013-03-28 | Class II | Packaging process control | Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. | A) Product Code 2N3371: 228,200 units | 2017-07-31 |
| 2012-12-14 | Class II | Unknown/Undetermined by firm | Some of the individual extension set packages were improperly sealed, compromising the sterility of the product. | 15,257 units | 2016-12-23 |
| 2012-09-07 | Class I | Device Design | Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. | 2,265,453 units | 2017-12-29 |
| 2012-09-07 | Class I | Device Design | Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. | 1,995,040 units | 2017-12-29 |
| 2012-09-07 | Class I | Device Design | Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. | 488,504 units | 2017-12-29 |
| 2012-09-07 | Class I | Device Design | Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. | 278,420 units | 2017-12-29 |
| 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 1,440 units | 2012-11-01 |
| 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 2,160 units | 2012-11-01 |
| 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 720 units | 2012-11-01 |
| 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 528 units | 2012-11-01 |
| 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 2,352 units | 2012-11-01 |
| 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 4,272 units | 2012-11-01 |
| 2011-07-06 | Not classified | Packaging | Some of the individual extension set packages were improperly sealed, compromising the sterility of the product. | 9,800 sets | 2012-04-18 |
| 2011-05-31 | Not classified | Employee error | The lot of Baxter Solution Set for Epidural Use is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the | 13,920 units | 2012-06-18 |
| 2010-10-21 | Not classified | Other | If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. | 752,965 units in US and all lots in Japan | 2011-10-16 |
| 2010-09-09 | Not classified | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. | 413,750 sets | 2011-09-07 |
| 2010-09-09 | Not classified | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. | 60,400 sets | 2011-09-07 |
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.