Arrow
Epidural Catheterization Kit with FlexTip Plus(R), Open Tip Single-Port Catheter and Needle Disposal Feature
1manufacturer
366catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K140110 |
| Record published | 2022-07-04 |
| Record revised | 2023-07-18 (version 12) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| 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 10, box of 10, case of 20, box of 5, case of 2 |
| Sizes | Length 0 to 90.17 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN924990 | In distribution | |
| IPN922624 | In distribution | |
| IPN930533 | In distribution | |
| IPN029817 | In distribution | |
| IPN045609 | In distribution | |
| IPN045691 | Length 90 cm | In distribution |
| IPN923961 | In distribution | |
| IPN927428 | In distribution | |
| IPN923967 | In distribution | |
| IPN923973 | In distribution | |
| IPN923956 | In distribution | |
| IPN921205 | In distribution | |
| IPN925034 | In distribution | |
| IPN924969 | In distribution | |
| IPN924017 | In distribution | |
| IPN924037 | In distribution | |
| IPN924978 | In distribution | |
| IPN923953 | In distribution | |
| IPN045676 | Length 90 cm | In distribution |
| IPN923959 | In distribution | |
| IPN038492 | In distribution | |
| IPN046641 | Length 90.17 cm | In distribution |
| IPN925053 | In distribution | |
| IPN046498 | Length 90 cm | In distribution |
| IPN923978 | In distribution | |
| IPN046495 | Length 90 cm | In distribution |
| IPN922629 | In distribution | |
| IPN924993 | In distribution | |
| IPN040052 | Length 90 cm | In distribution |
| IPN045608 | In distribution | |
| IPN028404 | In distribution | |
| IPN920780 | In distribution | |
| IPN925014 | In distribution | |
| IPN040178 | In distribution | |
| IPN923971 | In distribution | |
| IPN925032 | In distribution | |
| IPN046631 | Length 90 cm | In distribution |
| IPN925043 | In distribution | |
| IPN924972 | In distribution | |
| IPN923990 | In distribution | |
| IPN920760 | In distribution | |
| IPN924976 | In distribution | |
| IPN045732 | In distribution | |
| IPN037730 | In distribution | |
| IPN924026 | In distribution | |
| IPN923999 | In distribution | |
| IPN924043 | In distribution | |
| IPN045613 | Length 90 cm | In distribution |
| IPN046486 | Length 90 cm | In distribution |
| IPN925003 | In distribution | |
| IPN045994 | Length 90 cm | In distribution |
| IPN924020 | In distribution | |
| IPN923985 | In distribution | |
| IPN923977 | In distribution | |
| IPN045714 | In distribution | |
| IPN924973 | In distribution | |
| IPN045606 | Length 90 cm | In distribution |
| IPN925038 | In distribution | |
| IPN924996 | In distribution | |
| IPN046509 | Length 90 cm | In distribution |
| IPN040110 | In distribution | |
| IPN915657 | In distribution | |
| IPN045611 | Length 90 cm | In distribution |
| IPN046499 | Length 90 cm | In distribution |
| IPN923991 | In distribution | |
| IPN924994 | In distribution | |
| IPN056569 | In distribution | |
| IPN923983 | In distribution | |
| IPN038182 | In distribution | |
| IPN923972 | In distribution | |
| IPN925041 | In distribution | |
| IPN048026 | In distribution | |
| IPN923963 | In distribution | |
| IPN919608 | In distribution | |
| IPN045692 | Length 90 cm | In distribution |
| IPN048030 | In distribution | |
| IPN046629 | Length 90 cm | In distribution |
| IPN048021 | In distribution | |
| IPN046779 | Length 90 cm | In distribution |
| IPN920761 | In distribution | |
| IPN925023 | In distribution | |
| IPN924906 | In distribution | |
| IPN046486 | Length 90 cm | In distribution |
| IPN924970 | In distribution | |
| IPN923981 | In distribution | |
| IPN925002 | In distribution | |
| IPN925024 | In distribution | |
| IPN925040 | In distribution | |
| IPN924001 | In distribution | |
| IPN923998 | In distribution | |
| IPN920779 | In distribution | |
| IPN046379 | In distribution | |
| IPN923957 | In distribution | |
| IPN925012 | In distribution | |
| IPN045607 | In distribution | |
| IPN924986 | In distribution | |
| IPN055236 | In distribution | |
| IPN046779 | Length 90 cm | In distribution |
| IPN046438 | Length 90 cm | In distribution |
| IPN924982 | In distribution | |
| IPN046497 | Length 90 cm | In distribution |
| IPN045693 | Length 90 cm | In distribution |
| IPN925020 | In distribution | |
| IPN921047 | In distribution | |
| IPN925017 | In distribution | |
| IPN924998 | In distribution | |
| IPN927743 | In distribution | |
| IPN924021 | In distribution | |
| IPN045686 | In distribution | |
| IPN923947 | In distribution | |
| IPN046485 | Length 0 cm | In distribution |
| IPN927873 | In distribution | |
| IPN040123 | In distribution | |
| IPN046641 | Length 90.17 cm | In distribution |
| IPN925021 | In distribution | |
| IPN924022 | In distribution | |
| IPN045698 | Length 90 cm | In distribution |
| IPN055252 | In distribution | |
| IPN924977 | In distribution | |
| IPN045667 | Length 90 cm | In distribution |
| IPN045701 | In distribution | |
| IPN923964 | In distribution | |
| IPN925001 | In distribution | |
| IPN923988 | In distribution | |
| IPN923876 | In distribution | |
| IPN920769 | In distribution | |
| IPN046640 | Length 90.17 cm | In distribution |
| IPN056534 | In distribution | |
| IPN045609 | In distribution | |
| IPN923875 | In distribution | |
| IPN925045 | In distribution | |
| IPN925046 | In distribution | |
| IPN923992 | In distribution | |
| IPN924980 | In distribution | |
| IPN056655 | In distribution | |
| IPN923949 | In distribution | |
| IPN927742 | In distribution | |
| IPN045609 | In distribution | |
| IPN046510 | Length 90 cm | In distribution |
| IPN925049 | In distribution | |
| IPN046490 | Length 90 cm | In distribution |
| IPN911814 | In distribution | |
| IPN925018 | In distribution | |
| IPN924018 | In distribution | |
| IPN919612 | In distribution | |
| IPN046631 | Length 90 cm | In distribution |
| IPN048025 | In distribution | |
| IPN919611 | In distribution | |
| IPN922619 | In distribution | |
| IPN045683 | Length 90 cm | In distribution |
| IPN029761 | In distribution | |
| IPN046573 | Length 90 cm | In distribution |
| IPN923950 | In distribution | |
| IPN045613 | Length 90 cm | In distribution |
| IPN045708 | Length 90 cm | In distribution |
| IPN923994 | In distribution | |
| IPN048023 | In distribution | |
| IPN927427 | In distribution | |
| IPN924985 | In distribution | |
| IPN045682 | Length 90 cm | In distribution |
| IPN923968 | In distribution | |
| IPN923965 | In distribution | |
| IPN045686 | Length 90 cm | In distribution |
| IPN045607 | In distribution | |
| IPN923952 | In distribution | |
| IPN924034 | In distribution | |
| IPN922630 | In distribution | |
| IPN924000 | In distribution | |
| IPN045653 | In distribution | |
| IPN048022 | In distribution | |
| IPN046728 | Length 90.17 cm | In distribution |
| IPN923960 | In distribution | |
| IPN046498 | Length 90 cm | In distribution |
| IPN045713 | Length 90 cm | In distribution |
| IPN040112 | Length 90 cm | In distribution |
| IPN048028 | In distribution | |
| IPN919184 | In distribution | |
| IPN923975 | In distribution | |
| IPN924999 | In distribution | |
| IPN920763 | In distribution | |
| IPN046555 | Length 8.89 cm | In distribution |
| IPN923976 | In distribution | |
| IPN922619 | In distribution | |
| IPN923948 | In distribution | |
| IPN925295 | In distribution | |
| IPN048027 | In distribution | |
| IPN925007 | In distribution | |
| IPN924004 | In distribution | |
| IPN923974 | In distribution | |
| IPN924005 | In distribution | |
| IPN922621 | In distribution | |
| IPN923958 | In distribution | |
| IPN924033 | In distribution | |
| IPN056376 | In distribution | |
| IPN040130 | Length 0 cm | In distribution |
| IPN925050 | In distribution | |
| IPN045707 | Length 90 cm | In distribution |
| IPN029761 | In distribution | |
| IPN038181 | In distribution | |
| IPN046779 | Length 90 cm | In distribution |
| IPN924968 | In distribution | |
| IPN924015 | In distribution | |
| IPN919979 | In distribution | |
| IPN924007 | In distribution | |
| IPN924988 | In distribution | |
| IPN927744 | In distribution | |
| IPN925008 | In distribution | |
| IPN924971 | In distribution | |
| IPN048022 | In distribution | |
| IPN925035 | In distribution | |
| IPN046486 | Length 90 cm | In distribution |
| IPN039534 | In distribution | |
| IPN045687 | In distribution | |
| IPN048025 | In distribution | |
| IPN045711 | Length 90 cm | In distribution |
| IPN925013 | In distribution | |
| IPN925037 | In distribution | |
| IPN046308 | Length 90 cm | In distribution |
| IPN039533 | In distribution | |
| IPN045717 | Length 90 cm | In distribution |
| IPN047003 | In distribution | |
| IPN924023 | In distribution | |
| IPN046509 | Length 90 cm | In distribution |
| IPN046490 | Length 90 cm | In distribution |
| IPN048021 | In distribution | |
| IPN925055 | In distribution | |
| IPN045613 | Length 90 cm | In distribution |
| IPN923996 | In distribution | |
| IPN046629 | Length 90 cm | In distribution |
| IPN039534 | In distribution | |
| IPN924003 | In distribution | |
| IPN920772 | In distribution | |
| IPN924967 | In distribution | |
| IPN040164 | Length 90 cm | In distribution |
| IPN925004 | In distribution | |
| IPN925052 | In distribution | |
| IPN922623 | In distribution | |
| IPN924991 | In distribution | |
| IPN925022 | In distribution | |
| IPN040094 | Length 90 cm | In distribution |
| IPN045664 | Length 90 cm | In distribution |
| IPN046378 | In distribution | |
| IPN920059 | In distribution | |
| IPN040052 | Length 90 cm | In distribution |
| IPN040140 | In distribution | |
| IPN045669 | Length 90 cm | In distribution |
| IPN039613 | In distribution | |
| IPN924036 | In distribution | |
| IPN923970 | In distribution | |
| IPN046509 | Length 90 cm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epimed | Epimed International, Inc. | 56 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Halyard | Avanos Medical, Inc. | 34 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| Spinaut-E | Imedicom Co., Ltd. | 9 |
| E-Cath® NRFit Tsui® | Pajunk Gmbh Medizintechnologie | 6 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230603 | 2023-08-30 |
| K140110 | 2015-03-27 |
Recalls Naming This Product
9 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 | 1,525,831 | |
| 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 | 190 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-08 | Class II | Under Investigation by firm | Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. | 109 eaches (US), 23,021 (OUS) | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-01-15 | Class II | Other | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. | 343,105 total | 2023-03-17 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-01-15 | Class II | Other | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. | 343,105 total | 2023-03-17 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-01-15 | Class II | Other | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. | 343,105 total | 2023-03-17 |
| 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 | 250 units | 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 | 2019-12-20 | Class II | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product | 205 | 2021-02-25 |
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.