Magellan
Magellan, Hypodermic Safety Needle, Yellow Hub 20 G x 1-1/2" (0.9 mm x 38 mm),
71manufacturers in China registered for this device type
17catalogue numbers in this listing
23recalls on this code
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2026-03-17 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 50, case of 4 |
| Sizes | Length 0.63 to 1.5 in; needle gauge 18 to 25 G |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8881811510 | In distribution | ||
| 7777866403 | Length 1 in | 2,000 | In distribution |
| 7777850400 | Length 1.5 in | 2,000 | In distribution |
| 7777850401 | Length 1.5 in | 2,000 | In distribution |
| 7777866404 | Needle Gauge 22 G | 2,000 | In distribution |
| 8881811310 | In distribution | ||
| 7777866402 | Needle Gauge 23 G | 2,000 | In distribution |
| 8881811558 | In distribution | ||
| 7777850815 | Length 1.50 in | 2,000 | Withdrawn |
| 7777850010 | Length 1 in | 2,000 | Withdrawn |
| 7777850015 | Length 1.50 in | 2,000 | Withdrawn |
| 7777850510 | Length 1 in | 2,000 | Withdrawn |
| 7777850915 | Length 1.50 in | 2,000 | Withdrawn |
| 7777850558 | Length 0.63 in | 2,000 | Withdrawn |
| 7777850115 | Length 1.50 in | 2,000 | Withdrawn |
| 7777850810 | Length 1 in | 2,000 | Withdrawn |
| 7777850215 | Length 1.50 in | 2,000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
Recalls
23 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 |
|---|---|---|---|---|---|
| 2021-02-09 | Class II | Equipment maintenance | Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens | 108,000 units | 2024-04-09 |
| 2021-02-09 | Class II | Equipment maintenance | Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens | 243,250 units | 2024-04-09 |
| 2021-02-09 | Class II | Equipment maintenance | Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens | 6800 units | 2024-04-09 |
| 2020-09-25 | Class II | Under Investigation by firm | Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the ca | 519,676 units | 2023-10-30 |
| 2020-01-15 | Class II | Under Investigation by firm | Non-sterile product was shipped to customers. Product package is labeled as both “STERILE” and “NON-STERILR” ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in | 8000 | 2020-12-04 |
| 2020-01-15 | Class II | Under Investigation by firm | Non-sterile product was shipped to customers. Product package is labeled as both “STERILE” and “NON-STERILR” ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in | 2020-12-04 | |
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | ||
| 2019-04-30 | Class II | Under Investigation by firm | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product |
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.