Syringe 20ML E/T
Catalogue number 300613, listed by Becton, Dickinson & Co., United States, under Syringe, Piston. 60 manufacturers in China are registered for this product code.
60manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Becton, Dickinson & Co., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K110771 |
| Record published | 2016-09-19 |
| Record revised | 2025-07-30 (version 6) |
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 |
| Storage | Special storage condition: Fragile, handle with care; Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Shelfpack of 120, case of 4 |
| Sizes | Total volume 20 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 300613 | Total Volume 20 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
Showing 12 of 913. All products under Syringe, Piston
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170386 | 2017-04-12 |
| K113241 | 2011-11-28 |
| K091377 | 2009-07-02 |
| K042934 | 2004-10-28 |
| K024112 | 2003-01-09 |
Recalls Naming This Product
10 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 |
|---|---|---|---|---|---|---|---|
| Mentor Texas LP | 510(k) number | 2026-04-28 | Class II | Process control | A single lot of expired syringes were distributed due to a distribution system control failure. | 1401 syringes | |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 22,400 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 57600 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 340,000 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6. | 648,000 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 547,600 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 1,528,000 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-03-25 | Class II | Error in labeling | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices. | 176,000 units | 2017-04-03 |
| Becton, Dickinson & Co. | 510(k) number | 2016-03-25 | Class II | Error in labeling | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices. | 811,200 units | 2017-04-03 |
| Becton, Dickinson & Co. | 510(k) number | 2014-12-19 | Class II | Device Design | The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. | 564,000 units | 2015-12-07 |
Recalls
13 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 |
|---|---|---|---|---|---|
| 2026-01-27 | Class II | Under Investigation by firm | During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. | 204,000 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 45, 000 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 1,168,000 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 961,000 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 80,500 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 1,921,000 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 1,129,000 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 686,500 units | |
| 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 1,472,400 units | |
| 2020-12-23 | Class II | Process control | The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe. | 155,200 needles | 2022-11-21 |
| 2019-02-01 | Class II | Under Investigation by firm | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines. | 460,800 | 2020-06-11 |
| 2017-05-25 | Class II | Labeling mix-ups | Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G, Cat (Ref) 328468. T | 7,839,340 units | 2018-06-27 |
| 2012-10-02 | Class II | Mixed-up of materials/components | BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot. | 2,786,000 units | 2016-05-03 |
| 2009-11-23 | Not classified | Other | Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised. | 166240 units | 2010-04-06 |
| 2009-07-07 | Not classified | Packaging process control | Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes. | 133,600 units | 2009-10-02 |
| 2009-04-30 | Not classified | Nonconforming Material/Component | Potential for compromised sterility: Insufficient packaging seals. | 201,600 units | 2009-09-28 |
| 2008-07-15 | Not classified | Package design/selection | Becton Dickinson identified the presence of open seals during an internal inspection process. | 1246 lots | 2009-04-16 |
| 2008-01-07 | Not classified | Packaging | Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility. | 1,754,100 | 2008-05-19 |
| 2008-01-07 | Not classified | Packaging | Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility. | 2,926,560 | 2008-05-19 |
| 2007-04-09 | Not classified | Other | Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity. | 174,300 units | 2007-08-09 |
| 2007-02-15 | Not classified | Other | The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size. | 332,400 units | 2007-07-19 |
| 2007-01-27 | Not classified | Other | The needle becomes detached from the hub/syringe | 247,824 units | 2007-07-24 |
| 2005-10-25 | Not classified | Other | Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick. | 6920 cases — 2768000 syringes | 2006-06-21 |
| 2005-10-25 | Not classified | Other | Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick. | 2495 cases — 2495000 syringes | 2006-06-21 |
| 2005-05-25 | Not classified | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. | 322560 units | 2005-12-02 |
| 2005-05-25 | Not classified | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. | 1200 units | 2005-12-02 |
| 2005-05-25 | Not classified | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. | 691200 units | 2005-12-02 |
| 2005-05-25 | Not classified | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. | 409200 units | 2005-12-02 |
| 2005-05-25 | Not classified | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. | 811200 units | 2005-12-02 |
| 2005-05-25 | Not classified | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. | 2028000 units | 2005-12-02 |
| 2004-10-22 | Not classified | Other | Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga). | 1543000 syringes | 2006-04-14 |
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.