Vacuette
SAFETY Blood Collection Set + Blood Culture Holder 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex
23manufacturers in China registered for this device type
106catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (6), Shanghai (3). 4 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 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Jiangsu Rongye Technology Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 16 |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 11 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
Showing 12 of 23. All 23 manufacturers in China registered for Tubes, Vials, Systems, Serum Separators, Blood Collection
Record
| Listed by | Greiner BIO-ONE Gmbh, Austria |
|---|---|
| FDA product code | JKA |
| Device type | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1675 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | BK040066 |
| Record published | 2016-09-20 |
| Record revised | 2021-12-06 (version 6) |
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, expiry date |
| Storage | Storage environment temperature 4 to 25 °C |
| Packaging | Pack of 24, pack of 10, pack of 20, pack of 8 |
| Distribution end date | 2024-07-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 456293P | 50 | In distribution | |
| 484528 | 50 | In distribution | |
| 454371H | 50 | In distribution | |
| 456020 | 50 | In distribution | |
| 456018PCA | 50 | In distribution | |
| 454236 | 50 | In distribution | |
| 454067SLV | 50 | In distribution | |
| 454085 | 50 | In distribution | |
| 455084 | 50 | In distribution | |
| 456073P | 50 | In distribution | |
| 450209 | 100 | In distribution | |
| 456240 | 50 | In distribution | |
| 456292P | 50 | In distribution | |
| 454428 | 50 | In distribution | |
| 454370H | 50 | In distribution | |
| 454244 | 50 | In distribution | |
| 454237 | 50 | In distribution | |
| 454033 | 50 | In distribution | |
| 454029 | 50 | In distribution | |
| 455099P | 50 | In distribution | |
| 456028 | 50 | In distribution | |
| 454258 | 50 | In distribution | |
| 454067P | 50 | In distribution | |
| 456289PCA | 50 | In distribution | |
| 456275 | 50 | In distribution | |
| 456245 | 50 | In distribution | |
| 455047P | 50 | In distribution | |
| 456085 | 50 | In distribution | |
| 456062 | 50 | In distribution | |
| 455096 | 50 | In distribution | |
| 456286 | 50 | In distribution | |
| 454208 | 50 | In distribution | |
| 456087PCA | 50 | In distribution | |
| 454081 | 50 | In distribution | |
| 454241 | 50 | In distribution | |
| 456018P | 50 | In distribution | |
| 454484 | 50 | In distribution | |
| 454446P | 50 | In distribution | |
| 454493P | 50 | In distribution | |
| 486073P | 50 | In distribution | |
| 454371 | 50 | In distribution | |
| 456279 | 50 | In distribution | |
| 456291P | 50 | In distribution | |
| 454246CA | 50 | In distribution | |
| 456002CA | 50 | In distribution | |
| 454241H | 50 | In distribution | |
| 450182 | In distribution | ||
| 454221 | 50 | In distribution | |
| 455083P | 50 | In distribution | |
| 454008P | 50 | In distribution | |
| 484493P | 50 | In distribution | |
| 456020CA | 50 | In distribution | |
| 454243P | 50 | In distribution | |
| 455051 | 50 | In distribution | |
| 454247P | 50 | In distribution | |
| 454228P | 50 | In distribution | |
| 456089 | 50 | In distribution | |
| 450181 | 40 | In distribution | |
| 455001 | 50 | In distribution | |
| 454372H | 50 | In distribution | |
| 454030 | 50 | In distribution | |
| 454204 | 50 | In distribution | |
| 454297 | 50 | In distribution | |
| 456287P | 50 | In distribution | |
| 456043 | 50 | In distribution | |
| 456002 | 50 | In distribution | |
| 454370 | 50 | In distribution | |
| 456044P | 50 | In distribution | |
| 454372 | 50 | In distribution | |
| 454490PCA | 50 | In distribution | |
| 455093 | 50 | In distribution | |
| 486089 | 50 | In distribution | |
| 456087P | 50 | In distribution | |
| SA1396 | 50 | In distribution | |
| 454238 | 50 | In distribution | |
| 454240 | 50 | In distribution | |
| 455071P | 50 | In distribution | |
| 456283 | 50 | In distribution | |
| 455092 | 50 | In distribution | |
| 450184 | In distribution | ||
| 456088 | 50 | In distribution | |
| 456285 | 50 | In distribution | |
| 484507 | 50 | In distribution | |
| 455043P | 50 | In distribution | |
| 456024P | 50 | In distribution | |
| 450183 | In distribution | ||
| 450185 | In distribution | ||
| 454246 | 50 | In distribution | |
| 454029H | 50 | Withdrawn | |
| 455092CSS | 50 | Withdrawn | |
| 456048 | 50 | Withdrawn | |
| 454204H | 50 | Withdrawn | |
| 454297CA | 50 | Withdrawn | |
| 455010P | 50 | Withdrawn | |
| 454067PH | 50 | Withdrawn | |
| 454318H | 50 | Withdrawn | |
| 456089H | 50 | Withdrawn | |
| 455232P | 50 | Withdrawn | |
| 455092H | 50 | Withdrawn | |
| 454059P | 50 | Withdrawn | |
| 454030H | 50 | Withdrawn | |
| 454302 | 50 | Withdrawn | |
| 456073PH | 50 | Withdrawn | |
| 456016 | 50 | Withdrawn | |
| 456018PH | 50 | Withdrawn | |
| 454318 | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 182 |
| S-Monovette® | Sarstedt Aktiengesellschaft & Co.KG | 108 |
| Jelco | ICU Medical, Inc | 35 |
| Kbmed | KB Medical (Group) Inc. | 33 |
| Marketlab Inc | Marketlab Incorporated | 30 |
| Maveric Medical | Maveric Medical LLC | 27 |
| Safe-T-Fill® | Ram Scientific | 23 |
| Improvacuter® Gel & Clot Activator Tube | Guangzhou Improve Medical Instruments Co., Ltd. | 21 |
| Medline | Medline Industries, Inc. | 20 |
| Kurin Blood Culture Collection Set | Kurin, Inc. | 20 |
| Reli | Myco Medical Supplies, Inc. | 18 |
| icu medical | Jiangsu Caina Medical Co., Ltd. | 18 |
Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection
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 |
|---|---|---|---|---|---|---|---|
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2025-08-19 | Class II | Labeling Change Control | Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may resu | 1,980,000 | |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2024-05-14 | Class II | Employee error | The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay o | 1,008,000pcs (840 cartons) | |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2023-12-12 | Class II | Software design | Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose resul | 495,600 tubes | |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2021-12-09 | Class II | Under Investigation by firm | Some of the blood collection tubes show clotting due to variation of Lithium Heparin. | 889,200 pcs. | 2023-10-10 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2021-08-13 | Class II | Process control | Blood collection tubes may experience a clotting issue. | 962,400 tubes | 2023-08-16 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2019-11-25 | Class II | Process control | The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume. | 1,002,000 tubes | 2020-10-05 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2016-04-26 | Class II | Process control | The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate. | 250,800 pieces (209 cases) | 2016-08-22 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2011-12-14 | Not classified | Material/Component Contamination | The lithium heparin tubes may have a contamination with EDTA potassium. | 2,082,000 pieces | 2012-06-21 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2011-08-12 | Not classified | Process control | Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills. | 504,000 pieces | 2012-03-12 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2010-08-25 | Not classified | Other | Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results. | 18 cases (total 21,600 pieces) | 2012-05-15 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2008-07-29 | Not classified | Labeling mix-ups | Labeling Error: Incorrect tube label reads “Z Serum Clot Activator” instead of “LH Lithium Heparin” tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the corre | 33 cases (39,600 pieces) | 2009-08-26 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2005-07-28 | Not classified | Other | Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution. | 1623 cases (1,947,600 pieces) | 2005-11-16 |
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.