Clearlink
Luer Activated Universal Vial Adapter
8manufacturers in China registered for this device type
1catalogue number
12510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (3), Hong Kong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Zhejiang Medtec Medical devices Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 10 |
| Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | LHI |
| Device type | Set, I.V. Fluid Transfer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K924064 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 200 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2N8395 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kenaflexx | Kentron Healthcare, Inc. | 49 |
| Set, I.V. Fluid Transfer | Mps Medical, Inc. | 27 |
| Vial Adaptor | West Pharma. Services IL, Ltd. | 26 |
| Vial Adapter | West Pharma. Services IL, Ltd. | 22 |
| Extension SET | MPS Pharma & Medical, Inc. | 19 |
| Vial Adapter Medic’up | Union Plastic | 17 |
| Exactamix | Baxter Healthcare Corporation | 16 |
| Mix2Vial Transfer Device | West Pharma. Services IL, Ltd. | 15 |
| Arisure | Yukon Medical, LLC | 13 |
| ViaLok | Yukon Medical, LLC | 12 |
| ICU Medical | ICU Medical, Inc | 12 |
| Codan | Codan US Corp. | 10 |
Showing 12 of 233. All products under Set, I.V. Fluid Transfer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142600 | 2014-11-19 |
| K092318 | 2009-10-30 |
| K042410 | 2004-10-08 |
| K003730 | 2000-12-20 |
| K973654 | 1997-10-24 |
| K961008 | 1997-10-10 |
| K955622 | 1997-05-06 |
| K924064 | 1993-04-21 |
| K910793 | 1991-03-21 |
| K894827 | 1989-10-06 |
| K884626 | 1988-11-22 |
| K852467 | 1985-10-17 |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2024-08-20 | Class I | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaM | 2,140,046 units | |
| 2024-08-20 | Class I | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaM | 3,580,283 units | |
| 2024-08-20 | Class I | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaM | 5,828,540 units | |
| 2024-08-20 | Class I | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaM | 1,548,782 units | |
| 2023-12-22 | Class I | Device Design | An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volu | 67 devices | |
| 2023-12-22 | Class I | Device Design | An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volu | 8 devices | |
| 2022-07-14 | Class II | Process control | There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. | 448,960 units | |
| 2019-09-18 | Class II | Process control | Potential ability to leak once used for compounding. | 11,389,800 units total | 2021-02-16 |
| 2018-04-25 | Class II | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiratio | 98700 units | 2020-12-16 |
| 2018-04-25 | Class II | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiratio | 59475 units | 2020-12-16 |
| 2018-04-25 | Class II | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiratio | 75350 units | 2020-12-16 |
| 2018-04-25 | Class II | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiratio | 112975 units | 2020-12-16 |
| 2014-06-10 | Class II | Software design | If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which co | 1758 | 2017-02-22 |
| 2013-09-25 | Class II | Packaging process control | Incomplete foil seal on one lot of sterile product. | 38,400 units | 2014-07-22 |
| 2011-08-15 | Not classified | Software design | There is the potential for an order entry error during use of the LOGIX Order Entry (OE) software. When adding ingredients to a TPN order, the user can accept the pre-populated “per units” of “Bag” or select other “per units”. A dosing er | 95 units | 2017-01-05 |
| 2011-03-29 | Not classified | Software design | The LOGIX OE automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. The software stores backup files in numeric order rather than chronological date ord | 84 units | 2017-01-05 |
| 2011-01-27 | Not classified | Other | The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from | 3100 units | 2012-02-16 |
| 2011-01-27 | Not classified | Other | The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from | 950 units | 2012-02-16 |
| 2011-01-27 | Not classified | Other | The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from | 840 units | 2012-02-16 |
| 2011-01-27 | Not classified | Other | The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from | 270 units | 2012-02-16 |
| 2008-03-28 | Not classified | Software design | Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly. | 5 units | 2008-08-25 |
| 2004-12-20 | Not classified | Other | Logix-CM software version 3.0.4 has not completed its official release process. | 5 units | 2005-05-19 |
| 2004-12-08 | Not classified | Other | A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software. | 12 units | 2005-11-01 |
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.