Arrow
21 Ga. x 2-1/4 (5.7 cm) Echogenic Needle
71manufacturers in China registered for this device type
57catalogue numbers in this listing
3510(k) clearances naming this product code
6recalls 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180588 |
| Record published | 2024-02-26 |
| Record revised | 2025-09-08 (version 29) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | High-level Disinfectant |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep dry, Keep away from sunlight |
| Packaging | Box of 25, carton of 5, carton of 20, box of 5, box of 20, case of 5 |
| Distribution end date | 2025-08-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN923044 | In distribution | ||
| IPN917347 | In distribution | ||
| IPN922674 | In distribution | ||
| IPN029608 | In distribution | ||
| IPN036337 | In distribution | ||
| IPN923052 | In distribution | ||
| IPN033743 | In distribution | ||
| IPN915665 | In distribution | ||
| IPN038252 | In distribution | ||
| IPN923045 | In distribution | ||
| IPN033729 | In distribution | ||
| IPN038253 | In distribution | ||
| IPN923050 | In distribution | ||
| IPN922596 | In distribution | ||
| IPN919996 | In distribution | ||
| IPN035923 | 250 | In distribution | |
| IPN929092 | In distribution | ||
| IPN032659 | In distribution | ||
| IPN923036 | In distribution | ||
| IPN917337 | In distribution | ||
| IPN917322 | In distribution | ||
| IPN033726 | In distribution | ||
| IPN033332 | In distribution | ||
| IPN925156 | In distribution | ||
| IPN923042 | In distribution | ||
| IPN055732 | In distribution | ||
| IPN033711 | In distribution | ||
| IPN033764 | In distribution | ||
| IPN917331 | In distribution | ||
| IPN917332 | In distribution | ||
| IPN922597 | In distribution | ||
| IPN923053 | In distribution | ||
| IPN038251 | In distribution | ||
| IPN930944 | In distribution | ||
| IPN917346 | In distribution | ||
| IPN033737 | In distribution | ||
| IPN923037 | In distribution | ||
| IPN038253 | In distribution | ||
| IPN055711 | In distribution | ||
| IPN032660 | In distribution | ||
| IPN917317 | In distribution | ||
| IPN917352 | In distribution | ||
| IPN035922 | In distribution | ||
| IPN033708 | In distribution | ||
| IPN033767 | In distribution | ||
| IPN917316 | In distribution | ||
| IPN033331 | In distribution | ||
| IPN033334 | In distribution | ||
| IPN033766 | In distribution | ||
| IPN033728 | In distribution | ||
| IPN033768 | In distribution | ||
| IPN033333 | In distribution | ||
| IPN915667 | In distribution | ||
| IPN923058 | In distribution | ||
| IPN033710 | In distribution | ||
| IPN038252 | Withdrawn | ||
| IPN038251 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231924 | 2023-07-25 |
| K202492 | 2021-03-22 |
| K180588 | 2018-04-17 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2024-07-26 | Class II | Nonconforming Material/Component | Reports have been received regarding open seals on the packaging. | 14,845 kits | |
| Teleflex Medical LLC | 510(k) number | 2019-10-08 | Class II | Package design/selection | The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the a | 526,000 total | |
| Teleflex Medical LLC | 510(k) number | 2019-10-08 | Class II | Package design/selection | The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the a | 526,000 total | |
| Teleflex Medical LLC | 510(k) number | 2019-10-08 | Class II | Package design/selection | The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the a | 526,000 total | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Teleflex Medical LLC | 510(k) number | 2015-05-12 | Class II | Device Design | Potential breach in sterility | 2,104 boxes | 2016-04-11 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-29 | Class III | Incorrect or no expiration date | Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. | 4760 eaches | 2024-04-19 |
| 2014-03-31 | Class II | Material/Component Contamination | The voluntary recall is due to the needle set not meeting its specifications. | 172 | 2015-01-30 |
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.