Arrow
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions
12manufacturers in China registered for this device type
2,368catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Foshan Special Medical Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K993691 |
| Record published | 2022-11-29 |
| Record revised | 2024-04-15 (version 27) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 25 °C; Special storage condition: Avoid excessive heat above 40C (104F). |
| Packaging | Case of 5, case of 10, case of 3, case of 2, box of 10 |
| Sizes | Catheter gauge 4 to 14 Fr; length 10 to 20 cm; catheter length 16 to 20 cm; length 4 in |
| Distribution end date | 2025-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN919454 | In distribution | |
| IPN037045 | In distribution | |
| IPN923111 | In distribution | |
| IPN030805 | In distribution | |
| IPN917111 | In distribution | |
| IPN056803 | In distribution | |
| IPN035961 | In distribution | |
| IPN030137 | In distribution | |
| IPN055817 | In distribution | |
| IPN037844 | In distribution | |
| IPN930945 | In distribution | |
| IPN036441 | In distribution | |
| IPN032927 | In distribution | |
| IPN030230 | In distribution | |
| IPN033995 | In distribution | |
| IPN055802 | In distribution | |
| IPN919434 | In distribution | |
| IPN920680 | In distribution | |
| IPN036455 | In distribution | |
| IPN036621 | In distribution | |
| IPN037293 | In distribution | |
| IPN036657 | In distribution | |
| IPN927741 | In distribution | |
| IPN035265 | In distribution | |
| IPN039841 | In distribution | |
| IPN032925 | In distribution | |
| IPN916434 | In distribution | |
| IPN029722 | In distribution | |
| IPNB00141 | In distribution | |
| IPN001317 | In distribution | |
| IPN036645 | Catheter Gauge 7 Fr | In distribution |
| IPN030233 | In distribution | |
| IPN037867 | In distribution | |
| IPN036878 | In distribution | |
| IPN030241 | In distribution | |
| IPN919436 | In distribution | |
| IPN036338 | In distribution | |
| IPN032933 | In distribution | |
| IPN055586 | In distribution | |
| IPN034801 | In distribution | |
| IPN036242 | In distribution | |
| IPN922915 | In distribution | |
| IPN032837 | In distribution | |
| IPN918703 | In distribution | |
| IPN034753 | In distribution | |
| IPN035110 | In distribution | |
| IPN036900 | In distribution | |
| IPN037607 | In distribution | |
| IPN055609 | In distribution | |
| IPN036837 | In distribution | |
| IPN035155 | In distribution | |
| IPN037266 | In distribution | |
| IPN030164 | In distribution | |
| IPN036493 | In distribution | |
| IPN037582 | In distribution | |
| IPN036592 | In distribution | |
| IPN919477 | In distribution | |
| IPN054709 | In distribution | |
| IPN038546 | In distribution | |
| IPN929362 | In distribution | |
| IPN038970 | In distribution | |
| IPN914822 | In distribution | |
| IPN036491 | In distribution | |
| IPN036899 | In distribution | |
| IPN037127 | In distribution | |
| IPN037147 | In distribution | |
| IPN036346 | In distribution | |
| IPN030118 | In distribution | |
| IPN036494 | In distribution | |
| IPN916998 | In distribution | |
| IPN036287 | In distribution | |
| IPN037836 | In distribution | |
| IPN037269 | In distribution | |
| IPN034985 | In distribution | |
| IPN916838 | In distribution | |
| IPN054726 | In distribution | |
| IPN916438 | In distribution | |
| IPN056544 | In distribution | |
| EDC-00620 | In distribution | |
| IPN036688 | In distribution | |
| IPN034948 | In distribution | |
| IPN034966 | In distribution | |
| IPN034892 | In distribution | |
| IPN035565 | In distribution | |
| IPN055807 | In distribution | |
| IPN929015 | In distribution | |
| IPN032933 | In distribution | |
| IPN038183 | In distribution | |
| IPN035242 | In distribution | |
| IPN034916 | In distribution | |
| IPN928003 | In distribution | |
| EDC-00620-M | In distribution | |
| EDC-00622-HC | In distribution | |
| IPN034649 | In distribution | |
| IPN921115 | In distribution | |
| IPN038404 | In distribution | |
| IPN036698 | In distribution | |
| IPN055791 | In distribution | |
| IPN034890 | In distribution | |
| IPN035185 | In distribution | |
| IPN035482 | In distribution | |
| IPN030140 | In distribution | |
| IPN030136 | In distribution | |
| IPN054710 | In distribution | |
| IPN055563 | In distribution | |
| IPN037028 | In distribution | |
| IPN037455 | In distribution | |
| IPN039931 | In distribution | |
| IPN030192 | In distribution | |
| IPN930081 | In distribution | |
| IPN029774 | In distribution | |
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| IPN035314 | In distribution | |
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| IPN036880 | In distribution | |
| IPN914882 | In distribution | |
| IPN037074 | In distribution | |
| IPN030144 | In distribution | |
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| IPN055588 | In distribution | |
| IPN055205 | In distribution | |
| IPN032750 | In distribution | |
| IPN055240 | In distribution | |
| IPN917114 | In distribution | |
| IPN035343 | In distribution | |
| IPN036666 | In distribution | |
| IPN035139 | In distribution | |
| IPN919447 | In distribution | |
| IPN037868 | In distribution | |
| IPN927502 | In distribution | |
| IPN034035 | In distribution | |
| EDC-00820-HB | In distribution | |
| IPN914892 | In distribution | |
| IPN917422 | In distribution | |
| IPN036871 | Catheter Gauge 5.5 Fr | In distribution |
| IPN035351 | In distribution | |
| IPN920320 | In distribution | |
| IPN034862 | In distribution | |
| IPN055249 | In distribution | |
| IPN055584 | In distribution | |
| IPN034984 | In distribution | |
| IPN035488 | In distribution | |
| IPN036577 | In distribution | |
| IPN030233 | Catheter Gauge 7 Fr | In distribution |
| IPN030095 | In distribution | |
| IPN034767 | In distribution | |
| IPN038405 | In distribution | |
| IPN036990 | In distribution | |
| IPN030142 | In distribution | |
| IPN036326 | In distribution | |
| IPN036355 | In distribution | |
| IPN032919 | In distribution | |
| IPN036526 | In distribution | |
| IPN037142 | In distribution | |
| IPN914764 | In distribution | |
| IPN034048 | In distribution | |
| IPN036654 | In distribution | |
| IPNB00093 | In distribution | |
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| IPN030183 | In distribution | |
| IPN034613 | In distribution | |
| IPN035197 | In distribution | |
| IPN032985 | In distribution | |
| IPN029605 | In distribution | |
| IPN034927 | In distribution | |
| IPN032793 | In distribution | |
| IPN036640 | In distribution | |
| IPN036857 | In distribution | |
| IPN056726 | In distribution | |
| IPN034921 | In distribution | |
| IPN036800 | In distribution | |
| IPN927374 | In distribution | |
| IPN030200 | In distribution | |
| IPN035122 | In distribution | |
| IPN921391 | In distribution | |
| IPN030141 | In distribution | |
| IPN030243 | In distribution | |
| IPN055758 | In distribution | |
| IPN015949 | In distribution | |
| IPN029606 | In distribution | |
| IPN927213 | In distribution | |
| IPN036526 | In distribution | |
| IPN036498 | In distribution | |
| IPNB00148 | In distribution | |
| IPN034047 | In distribution | |
| IPN916803 | In distribution | |
| IPN037665 | In distribution | |
| IPN036588 | In distribution | |
| IPN922675 | In distribution | |
| IPN034052 | In distribution | |
| IPN030229 | In distribution | |
| IPN032875 | In distribution | |
| IPN036358 | In distribution | |
| IPN035149 | In distribution | |
| IPN036462 | In distribution | |
| IPN917113 | In distribution | |
| IPN036696 | In distribution | |
| IPN037241 | In distribution | |
| IPN055203 | In distribution | |
| IPN055170 | In distribution | |
| IPN055565 | In distribution | |
| IPN034646 | In distribution | |
| IPN029716 | In distribution | |
| IPN928111 | In distribution | |
| IPN915614 | In distribution | |
| IPN922908 | In distribution | |
| IPN916994 | In distribution | |
| IPN032810 | In distribution | |
| IPN055726 | In distribution | |
| IPN055801 | In distribution | |
| IPN035209 | In distribution | |
| IPN037182 | In distribution | |
| IPN920129 | In distribution | |
| IPN035619 | In distribution | |
| IPN034635 | In distribution | |
| IPN036627 | In distribution | |
| IPN036680 | In distribution | |
| IPN036219 | In distribution | |
| IPN036700 | In distribution | |
| IPN036440 | In distribution | |
| IPN036097 | In distribution | |
| IPN035030 | In distribution | |
| IPN038408 | In distribution | |
| IPN920319 | In distribution | |
| IPN036468 | In distribution | |
| IPN919654 | In distribution | |
| IPN929712 | In distribution | |
| IPN037577 | In distribution | |
| EDC-00622 | In distribution | |
| IPN037797 | In distribution | |
| IPN921389 | In distribution | |
| IPN035567 | In distribution | |
| IPN033122 | In distribution | |
| IPN036790 | In distribution | |
| IPN037187 | In distribution | |
| IPN919655 | In distribution | |
| IPN037080 | In distribution | |
| IPN036708 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 250 |
| Cook Spectrum | Cook Incorporated | 225 |
| Jelco | ICU Medical, Inc | 104 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| PowerGlide Pro | Bard Access Systems, Inc. | 63 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 62 |
| Able Central Venous Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 62 |
| Curaplex | Bound Tree Medical, LLC | 61 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
| Cragg-McNamaraTM | Micro Therapeutics, Inc. | 57 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Recalls Naming This Product
158 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) | 510(k) number | 2026-03-11 | Class II | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | 395 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2026-03-11 | Class II | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | 5 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2026-03-11 | Class II | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | 90 | |
| Medline Industries, LP – Northfield | 510(k) number | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 15 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2023-08-10 | Class I | Under Investigation by firm | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. | 180 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2023-08-10 | Class I | Under Investigation by firm | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. | 380 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2023-05-19 | Class I | Under Investigation by firm | Potential for catheter separation or leakage | 262,016 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-27 | Class I | Process design | There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Th | 80 units | 2024-10-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-27 | Class I | Process design | There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Th | 1275 units | 2024-10-07 |
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 5 each | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-05-05 | Class II | Error in labeling | Gravity flow rates on the affected product lidstock are incorrect. | 10,301 units | 2024-09-04 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2021-01-06 | Class II | Under Investigation by firm | The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard | 1,705 eaches | 2022-07-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-12-06 | Class II | Employee error | Potential sterility issue for specific lots of the Arrow Endurance” Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. | 575 | 2021-11-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-07-18 | Class II | Packaging process control | Arrow AGB+ Multi-Lumen CVC Kit – lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length | 745 eaches | 2020-11-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-05-17 | Class II | Employee error | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner. | 3,143 | 2020-09-24 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-09-21 | Class II | Employee error | The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is.032 rather than the correct SWG size.025. For other lots in scope the l | 3640 | 2020-09-23 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-08-30 | Class II | Under Investigation by firm | The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifies an incorrect expiration date. Per sta | 105 | 2020-07-31 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-07-10 | Class II | Under Investigation by firm | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. | 7024 units | 2020-05-27 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-07-10 | Class II | Under Investigation by firm | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. | 5507 units | 2020-05-27 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-07-03 | Class II | Employee error | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries | 166 | 2020-04-29 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Showing 40 of 158.
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.