Arrow
PICC Two-Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip(R) PICC Two-Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter Seldinger Access Set
5manufacturers in China registered for this device type
1,548catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K153423 |
| Record published | 2021-11-15 |
| Record revised | 2025-02-07 (version 20) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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 | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5, case of 3, case of 10, case, box of 25 |
| Sizes | Catheter gauge 4 to 6 Fr; length 55 to 130 cm; length 22.6875 in |
| Distribution end date | 2025-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN919539 | In distribution | |
| IPN035553 | In distribution | |
| IPN035607 | In distribution | |
| IPN032894 | In distribution | |
| IPN919400 | In distribution | |
| IPN055789 | In distribution | |
| IPN920209 | In distribution | |
| IPN033259 | In distribution | |
| IPN001203 | In distribution | |
| IPN033431 | In distribution | |
| IPN037629 | Catheter Gauge 5.5 Fr | In distribution |
| IPN032722 | In distribution | |
| IPN035553 | In distribution | |
| IPN001331 | In distribution | |
| IPN056680 | In distribution | |
| IPN925083 | In distribution | |
| IPN035441 | In distribution | |
| IPN920523 | In distribution | |
| IPN033530 | In distribution | |
| IPN032894 | Catheter Gauge 5 Fr | In distribution |
| IPN033479 | In distribution | |
| IPN036769 | In distribution | |
| IPN922927 | In distribution | |
| IPN032854 | In distribution | |
| IPN036813 | In distribution | |
| IPN930597 | In distribution | |
| IPN033545 | In distribution | |
| IPN036769 | In distribution | |
| IPN914839 | In distribution | |
| IPN914715 | In distribution | |
| IPN923012 | In distribution | |
| IPN033155 | In distribution | |
| IPN037302 | Catheter Gauge 4.5 Fr | In distribution |
| IPN036748 | In distribution | |
| IPN928814 | In distribution | |
| IPN033162 | In distribution | |
| IPN039570 | Catheter Gauge 4.5 Fr | In distribution |
| IPN920847 | In distribution | |
| IPN914718 | In distribution | |
| IPN035417 | In distribution | |
| IPN035051 | In distribution | |
| IPN033295 | In distribution | |
| IPN033466 | In distribution | |
| IPN034410 | In distribution | |
| IPN033150 | Catheter Gauge 4 Fr | In distribution |
| IPN914872 | In distribution | |
| IPN914871 | In distribution | |
| IPN035555 | In distribution | |
| IPN036053 | In distribution | |
| IPN038968 | In distribution | |
| IPN037429 | In distribution | |
| IPN032721 | In distribution | |
| IPN930602 | In distribution | |
| IPN920056 | In distribution | |
| IPN033419 | In distribution | |
| IPN035405 | In distribution | |
| IPN919570 | In distribution | |
| IPN921956 | In distribution | |
| IPN032889 | In distribution | |
| IPN930596 | In distribution | |
| IPN926646 | In distribution | |
| IPN036406 | In distribution | |
| IPN033326 | In distribution | |
| IPN036730 | In distribution | |
| IPN038138 | In distribution | |
| IPN924158 | In distribution | |
| IPN033399 | In distribution | |
| IPN036752 | Catheter Gauge 6 Fr | In distribution |
| IPN037427 | In distribution | |
| IPN919541 | In distribution | |
| IPN033423 | In distribution | |
| IPN033562 | In distribution | |
| IPN035536 | In distribution | |
| IPN035542 | In distribution | |
| IPN036319 | In distribution | |
| IPN036758 | In distribution | |
| IPN033324 | In distribution | |
| IPN032719 | In distribution | |
| IPN035048 | In distribution | |
| IPN033456 | Catheter Gauge 4 Fr | In distribution |
| IPN037424 | In distribution | |
| IPN033447 | In distribution | |
| IPN032847 | In distribution | |
| IPN035392 | In distribution | |
| IPN919559 | In distribution | |
| IPN919533 | In distribution | |
| IPN034854 | In distribution | |
| IPN056678 | In distribution | |
| IPN036816 | In distribution | |
| IPN036735 | In distribution | |
| IPN036761 | In distribution | |
| IPN926649 | In distribution | |
| IPN914840 | In distribution | |
| IPN037462 | In distribution | |
| IPN032675 | In distribution | |
| IPN035425 | In distribution | |
| IPN033359 | In distribution | |
| IPN919562 | In distribution | |
| IPN033349 | In distribution | |
| IPN035524 | In distribution | |
| IPN037876 | In distribution | |
| IPN036751 | In distribution | |
| IPN033145 | In distribution | |
| IPN038641 | In distribution | |
| IPN035598 | In distribution | |
| IPN928180 | In distribution | |
| IPN033010 | In distribution | |
| IPN914856 | In distribution | |
| IPN033306 | In distribution | |
| IPN033394 | In distribution | |
| IPN033317 | In distribution | |
| IPN036307 | In distribution | |
| IPN033492 | Catheter Gauge 5.5 Fr | In distribution |
| IPN033301 | In distribution | |
| IPN035582 | In distribution | |
| IPN032721 | In distribution | |
| IPN037878 | Catheter Gauge 6 Fr | In distribution |
| IPN035427 | Catheter Gauge 4.5 Fr | In distribution |
| IPN036807 | In distribution | |
| IPN034606 | In distribution | |
| IPN919563 | In distribution | |
| IPN038271 | In distribution | |
| IPN035470 | In distribution | |
| IPN033393 | In distribution | |
| IPN922928 | In distribution | |
| IPN928085 | In distribution | |
| IPN032717 | In distribution | |
| IPN037464 | In distribution | |
| IPN037448 | In distribution | |
| IPN919385 | In distribution | |
| IPN036737 | In distribution | |
| IPN920810 | In distribution | |
| IPN035551 | In distribution | |
| IPN036763 | In distribution | |
| IPN914865 | In distribution | |
| IPN035889 | In distribution | |
| IPN036731 | In distribution | |
| IPN037340 | In distribution | |
| IPN035541 | In distribution | |
| IPN037429 | In distribution | |
| IPN033472 | In distribution | |
| IPN055872 | In distribution | |
| IPN033262 | In distribution | |
| IPN924174 | In distribution | |
| IPN036806 | In distribution | |
| IPN919564 | In distribution | |
| IPN035571 | In distribution | |
| IPN036753 | In distribution | |
| IPN035549 | In distribution | |
| IPN926608 | In distribution | |
| IPN919389 | In distribution | |
| IPN038965 | In distribution | |
| IPN036421 | In distribution | |
| IPN035595 | In distribution | |
| IPN001341 | In distribution | |
| IPN920807 | In distribution | |
| IPN036427 | In distribution | |
| IPN930603 | In distribution | |
| IPN919573 | In distribution | |
| IPN034214 | In distribution | |
| IPN001337 | In distribution | |
| IPN037874 | In distribution | |
| IPN920064 | In distribution | |
| IPN920522 | In distribution | |
| IPN033441 | In distribution | |
| IPN001324 | In distribution | |
| IPN928813 | In distribution | |
| IPN033307 | In distribution | |
| IPN038537 | In distribution | |
| IPN036411 | In distribution | |
| IPN036732 | In distribution | |
| IPN036812 | In distribution | |
| IPN035601 | In distribution | |
| IPN056567 | In distribution | |
| IPN036810 | In distribution | |
| IPN033283 | In distribution | |
| IPN033455 | In distribution | |
| IPN033287 | In distribution | |
| IPN914836 | In distribution | |
| IPN036423 | In distribution | |
| IPN035449 | Catheter Gauge 6 Fr | In distribution |
| IPN036733 | In distribution | |
| IPN033526 | In distribution | |
| IPN035612 | In distribution | |
| IPN914855 | In distribution | |
| IPN037625 | Catheter Gauge 4.5 Fr | In distribution |
| IPN001327 | In distribution | |
| IPN928637 | In distribution | |
| IPN928630 | In distribution | |
| IPN033365 | In distribution | |
| IPN035545 | In distribution | |
| IPN033468 | In distribution | |
| IPN033371 | In distribution | |
| IPN033366 | In distribution | |
| IPN035419 | In distribution | |
| IPN928179 | In distribution | |
| IPN037705 | In distribution | |
| IPN914848 | In distribution | |
| IPN032676 | In distribution | |
| IPN920527 | In distribution | |
| IPN926609 | In distribution | |
| IPN035426 | In distribution | |
| IPN914731 | In distribution | |
| IPN033255 | In distribution | |
| IPN914857 | In distribution | |
| IPN033516 | In distribution | |
| IPN928636 | In distribution | |
| IPN915219 | In distribution | |
| IPNB00139 | In distribution | |
| IPN035463 | In distribution | |
| IPN038189 | In distribution | |
| IPN033383 | In distribution | |
| IPN037300 | Catheter Gauge 5.5 Fr | In distribution |
| IPN033324 | In distribution | |
| IPN033515 | In distribution | |
| IPN922922 | In distribution | |
| IPN033009 | In distribution | |
| IPN036424 | In distribution | |
| IPN928638 | In distribution | |
| IPN033258 | In distribution | |
| IPN033206 | In distribution | |
| IPN036405 | In distribution | |
| IPN926643 | In distribution | |
| IPN032715 | In distribution | |
| IPN036749 | In distribution | |
| IPN033302 | In distribution | |
| IPN036760 | Catheter Gauge 4 Fr | In distribution |
| IPN033480 | In distribution | |
| IPN923193 | In distribution | |
| IPN035461 | In distribution | |
| IPN033535 | In distribution | |
| IPN033382 | In distribution | |
| IPN035522 | In distribution | |
| IPN918530 | In distribution | |
| IPN033152 | Catheter Gauge 5 Fr | In distribution |
| IPN037427 | In distribution | |
| IPN036315 | In distribution | |
| IPN923192 | In distribution | |
| IPN930518 | In distribution | |
| IPN920798 | In distribution | |
| IPN001336 | In distribution | |
| IPN036768 | In distribution | |
| IPN928812 | In distribution | |
| IPN035603 | In distribution | |
| IPN039582 | Catheter Gauge 6 Fr | In distribution |
| IPN924182 | In distribution | |
| IPN038966 | In distribution | |
| IPN033322 | In distribution | |
| IPN036737 | In distribution | |
| IPN033264 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
| Vygon | Vygon Corp. | 50 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Recalls Naming This Product
62 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 |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 3,481 | |
| 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. | 1173 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. | 172 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2023-08-10 | Class II | 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. | 190 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2023-08-10 | Class II | 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. | 177 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-12-20 | Class II | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product | 2021-02-25 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-12-20 | Class II | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product | 2021-02-25 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 162 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 48 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 2021-01-13 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 350 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 279 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 450 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 2 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 1 unit | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 3 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 16 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 52 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 983 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 991 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 4345 units | 2021-01-13 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-12-13 | Class II | Employee error | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC | 963 units (US) in total | 2020-10-01 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-12-13 | Class II | Employee error | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC | 963 units (US) in total | 2020-10-01 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-07-17 | Class II | Under Investigation by firm | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen c | 1257 total | 2020-12-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-07-17 | Class II | Under Investigation by firm | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen c | 1257 total | 2020-12-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-05-17 | Class II | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. | 2070 units in total | 2020-12-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-05-17 | Class II | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. | 2070 units in total | 2020-12-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-05-17 | Class II | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. | 2070 units in total | 2020-12-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-05-17 | Class II | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. | 2070 units in total | 2020-12-02 |
| 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 | 2017-12-22 | Class II | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | 2020-05-27 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-11-27 | Class II | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. | 23,904 in total | 2020-09-22 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-17 | Class II | Mixed-up of materials/components | The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter. | 601 eaches | 2020-04-21 |
Showing 40 of 62.
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.