Monoject
Monoject Magellan 3/10 mL Insulin Safety Syringe, Permanent Needle Permanent Needle 29G x 1/2 in. (0.33 x 13 mm)
60manufacturers in China registered for this device type
83catalogue numbers in this listing
17recalls 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151949 |
| Record published | 2021-12-08 |
| Record revised | 2025-12-31 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, box of 100, case of 12, case of 4, box of 50, carton of 100 |
| Sizes | Total volume 0.3 to 60 ml; needle gauge 25 to 31 G; length 0.31 to 0.62 in; length 6 mm |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8881513207 | 25 | In distribution | |
| 8881892950 | Length 0.5 in | In distribution | |
| 11812558 | In distribution | ||
| 8881892930 | Length 0.5 in | In distribution | |
| 8881513918 | 100 | In distribution | |
| 11832010 | In distribution | ||
| 8881516200 | 25 | In distribution | |
| 11832510 | In distribution | ||
| 8881512852 | Total Volume 12 ml | 80 | In distribution |
| 11832210 | In distribution | ||
| 11832558 | In distribution | ||
| 1181620112 | In distribution | ||
| 8881513538 | 100 | In distribution | |
| 8881513058 | 100 | In distribution | |
| 8881513033 | 100 | In distribution | |
| 8881560232 | 10 | In distribution | |
| 8881613150 | Length 6 mm | In distribution | |
| 11832110 | In distribution | ||
| 1181621100 | In distribution | ||
| 8881893010 | Needle Gauge 30 G | In distribution | |
| 8881112059 | Total Volume 12 ml | 100 | In distribution |
| 8881512977 | Total Volume 12 ml | In distribution | |
| 8881512878 | Total Volume 12 ml | 80 | In distribution |
| 8881513132 | 100 | In distribution | |
| 11832315 | In distribution | ||
| 8881893150 | Length 6 mm | In distribution | |
| 8881500501 | Total Volume 0.5 ml | 25 | In distribution |
| 8881613130 | Needle Gauge 31 G | In distribution | |
| 8881513223 | 100 | In distribution | |
| 8881882812 | Length 0.5 in | In distribution | |
| 8881893030 | Length 0.31 in | In distribution | |
| 8881601101 | In distribution | ||
| 8881513744 | 100 | In distribution | |
| 8881893050 | Total Volume 0.5 ml | In distribution | |
| 8881103025 | 250 | In distribution | |
| 8881511235 | Needle Gauge 25 G | In distribution | |
| 8881513025 | 100 | In distribution | |
| 8881601600 | In distribution | ||
| 8881513256 | 100 | In distribution | |
| 8881513231 | 100 | In distribution | |
| 8881513934 | Total Volume 3 ml | 100 | In distribution |
| 8881892910 | Length 0.5 in | In distribution | |
| 8881513157 | 100 | In distribution | |
| 8881520251 | 25 | In distribution | |
| 11812705 | In distribution | ||
| 1181621112 | In distribution | ||
| 8881882712 | Total Volume 1 ml | In distribution | |
| 8881513330 | 100 | In distribution | |
| 1181622112 | In distribution | ||
| 11832115 | In distribution | ||
| 8881501236 | 25 | In distribution | |
| 8881601358 | In distribution | ||
| 8881501962 | 25 | In distribution | |
| 8881513702 | Total Volume 3 ml | 100 | In distribution |
| 8881613110 | Needle Gauge 31 G | In distribution | |
| 11832015 | In distribution | ||
| 8881512258 | 25 | In distribution | |
| 8881520178 | Total Volume 20 ml | In distribution | |
| 11813005 | In distribution | ||
| 1180300555 | Total Volume 3 ml | In distribution | |
| 8881511201 | Needle Gauge 28 G | In distribution | |
| 8881535101 | 10 | In distribution | |
| 8881112083 | Total Volume 12 ml | 800 | In distribution |
| 11832215 | In distribution | ||
| 8881513512 | 100 | In distribution | |
| 11832310 | In distribution | ||
| 8881501236 | 25 | Withdrawn | |
| 1180100777 | Withdrawn | ||
| 8881500501 | Total Volume 0.50 ml | 25 | Withdrawn |
| 1182000777 | Withdrawn | ||
| 8881601002 | Length 0.50 in | Withdrawn | |
| 1182000555 | Withdrawn | ||
| 8881501459 | Total Volume 1 ml | 25 | Withdrawn |
| 1180300777 | Withdrawn | ||
| 1180600777 | Withdrawn | ||
| 1180300555 | Total Volume 3 ml | Withdrawn | |
| 1183500555 | Withdrawn | ||
| 1183500777 | Withdrawn | ||
| 8881512878 | Total Volume 12 ml | 80 | Withdrawn |
| 8881511235 | Length 0.62 in | Withdrawn | |
| 1186060265 | Total Volume 60 ml | Withdrawn | |
| 8881103025 | 250 | Withdrawn | |
| 8881893050 | Total Volume 0.50 ml | Withdrawn |
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 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
| Integra® | Integra Pain Management | 77 |
Showing 12 of 913. All products under Syringe, Piston
Recalls Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 3,113,846 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 3,936,682 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 4,913,520 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 1,097,048 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-09-13 | Class II | Process change control | Syringe contains conical tip that is not compatible with certain needleless IV connector(s). | 3.927,994 units |
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 |
|---|---|---|---|---|
| 2026-02-27 | Class II | Under Investigation by firm | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes. | 198,900 units |
| 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 3,084,300 units |
| 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 457,200 units |
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.