Arrow
FlexBlock(R) Continuous Peripheral Nerve Block Kit with SnapTear(TM) Clear 5" Fenestrated Drape, Ultrasound Probe Cover, Sterile Gel and Needle Disposal Feature
1manufacturer
508catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K121403 |
| Record published | 2017-08-22 |
| Record revised | 2022-05-30 (version 11) |
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, box of 5, case of 25, case of 20 |
| Sizes | Length 0 to 90.17 cm; catheter gauge 3.2 Fr |
| Distribution end date | 2016-12-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN045586 | In distribution | |
| IPN046025 | Length 60 cm | In distribution |
| IPN040016 | In distribution | |
| IPN045655 | Length 90 cm | In distribution |
| IPN040165 | In distribution | |
| IPN922620 | In distribution | |
| IPN925120 | In distribution | |
| IPN919743 | In distribution | |
| IPN040032 | In distribution | |
| IPN040025 | In distribution | |
| IPN924963 | In distribution | |
| IPN040001 | In distribution | |
| IPN040139 | In distribution | |
| IPN045595 | In distribution | |
| IPN040030 | In distribution | |
| IPN924957 | In distribution | |
| IPN040200 | Length 90.17 cm | In distribution |
| IPN919744 | In distribution | |
| IPN040155 | In distribution | |
| IPN046021 | In distribution | |
| IPN925118 | In distribution | |
| IPN920598 | In distribution | |
| IPN047800 | In distribution | |
| IPN040035 | In distribution | |
| IPN040014 | In distribution | |
| IPN046738 | Length 90.17 cm | In distribution |
| IPN045750 | Length 60 cm | In distribution |
| IPN046187 | Length 0 cm | In distribution |
| IPN040057 | In distribution | |
| IPN046559 | Length 90 cm | In distribution |
| IPN032688 | In distribution | |
| IPN923945 | In distribution | |
| IPN046379 | In distribution | |
| IPN046019 | In distribution | |
| IPN045738 | In distribution | |
| IPN922599 | In distribution | |
| IPN045600 | In distribution | |
| IPN919607 | In distribution | |
| IPN029692 | In distribution | |
| IPN046016 | In distribution | |
| IPN921059 | In distribution | |
| IPN040017 | In distribution | |
| IPN045732 | In distribution | |
| IPN045735 | In distribution | |
| IPN040129 | In distribution | |
| IPN040101 | In distribution | |
| IPN922626 | In distribution | |
| IPN919734 | In distribution | |
| IPN045592 | Length 60 cm | In distribution |
| IPN045581 | In distribution | |
| IPN046025 | In distribution | |
| IPN045654 | In distribution | |
| IPN040046 | Length 0 cm | In distribution |
| IPN046356 | Length 0 cm | In distribution |
| IPN040058 | Length 12.5 cm | In distribution |
| IPN045756 | Length 60 cm | In distribution |
| IPN919737 | In distribution | |
| IPN046639 | Length 9.84 cm | In distribution |
| IPN045672 | In distribution | |
| IPN048793 | In distribution | |
| IPN046434 | Length 0 cm | In distribution |
| IPN924014 | In distribution | |
| IPN046639 | Length 9.84 cm | In distribution |
| IPN040008 | Length 60 cm | In distribution |
| IPN045594 | Length 9 cm | In distribution |
| IPN924013 | In distribution | |
| IPN046017 | In distribution | |
| IPN921052 | In distribution | |
| IPN040024 | In distribution | |
| IPN045943 | Length 8.89 cm | In distribution |
| IPN046487 | In distribution | |
| IPN925028 | In distribution | |
| IPN923877 | In distribution | |
| IPN040006 | Length 90 cm | In distribution |
| IPN925126 | In distribution | |
| IPN045662 | Length 90 cm | In distribution |
| IPN040002 | Length 5 cm | In distribution |
| IPN040154 | In distribution | |
| IPN040178 | Length 90 cm | In distribution |
| IPN046834 | In distribution | |
| IPN923939 | In distribution | |
| IPN919366 | In distribution | |
| IPN038175 | In distribution | |
| IPN040031 | In distribution | |
| IPN045662 | Length 90 cm | In distribution |
| IPN040007 | In distribution | |
| IPN040139 | In distribution | |
| IPN037310 | In distribution | |
| IPN925121 | In distribution | |
| IPN042604 | In distribution | |
| IPN040105 | In distribution | |
| IPN046020 | In distribution | |
| IPN040006 | In distribution | |
| IPN037745 | In distribution | |
| IPN045586 | Length 60 cm | In distribution |
| IPN036277 | In distribution | |
| IPN925031 | In distribution | |
| IPN040022 | In distribution | |
| IPN046313 | In distribution | |
| IPN046556 | Length 90 cm | In distribution |
| IPN040136 | Length 0 cm | In distribution |
| IPN048791 | In distribution | |
| IPN046311 | In distribution | |
| IPN045702 | In distribution | |
| IPN040052 | Length 90 cm | In distribution |
| IPN046013 | In distribution | |
| IPN040180 | Length 90 cm | In distribution |
| IPN045690 | Length 90 cm | In distribution |
| IPN045592 | In distribution | |
| IPN045596 | Length 15 cm | In distribution |
| IPN921060 | In distribution | |
| IPN920595 | In distribution | |
| IPN040156 | In distribution | |
| IPN045605 | Length 0 cm | In distribution |
| IPN040207 | In distribution | |
| IPN040012 | In distribution | |
| IPN037738 | In distribution | |
| IPN919746 | In distribution | |
| IPN040000 | In distribution | |
| IPN037394 | In distribution | |
| IPN928781 | In distribution | |
| IPN045583 | Length 60 cm | In distribution |
| IPN045610 | In distribution | |
| IPN920717 | In distribution | |
| IPN921061 | In distribution | |
| IPN040102 | In distribution | |
| IPN923940 | In distribution | |
| IPN046005 | Length 0 cm | In distribution |
| IPN921053 | In distribution | |
| IPN040025 | In distribution | |
| IPN040034 | Length 60 cm | In distribution |
| IPN038144 | In distribution | |
| IPN045749 | Length 60 cm | In distribution |
| IPN040048 | Length 9.84 cm | In distribution |
| IPN040035 | In distribution | |
| IPN040013 | In distribution | |
| IPN040037 | In distribution | |
| IPN045721 | Length 90 cm | In distribution |
| IPN923941 | In distribution | |
| IPN045592 | In distribution | |
| IPN037244 | In distribution | |
| IPN046365 | Length 9.84 cm | In distribution |
| IPN045582 | In distribution | |
| IPN045641 | Length 0 cm | In distribution |
| IPN045581 | In distribution | |
| IPN046378 | In distribution | |
| IPN046834 | In distribution | |
| IPN037318 | In distribution | |
| IPN046379 | In distribution | |
| IPN046437 | Length 0 cm | In distribution |
| IPN045598 | In distribution | |
| IPN040109 | In distribution | |
| IPN040107 | In distribution | |
| IPN040009 | In distribution | |
| IPN045582 | In distribution | |
| IPN040061 | In distribution | |
| IPN037242 | In distribution | |
| IPN040202 | Length 9.84 cm | In distribution |
| IPN045596 | Length 15 cm | In distribution |
| IPN037660 | In distribution | |
| IPN920597 | In distribution | |
| IPN046734 | In distribution | |
| IPN919736 | In distribution | |
| IPN040017 | In distribution | |
| IPN923214 | In distribution | |
| IPN045645 | Length 0 cm | In distribution |
| IPN040203 | In distribution | |
| IPN045583 | In distribution | |
| IPN038146 | In distribution | |
| IPN045651 | In distribution | |
| IPN046484 | Length 0 cm | In distribution |
| IPN919984 | In distribution | |
| IPN040001 | In distribution | |
| IPN046184 | Length 90 cm | In distribution |
| IPN046018 | In distribution | |
| IPN040023 | In distribution | |
| IPN047832 | In distribution | |
| IPN040003 | In distribution | |
| IPN046487 | In distribution | |
| IPN924011 | In distribution | |
| IPN045582 | Length 60 cm | In distribution |
| IPN037317 | In distribution | |
| IPN045584 | Length 60 cm | In distribution |
| IPN048791 | In distribution | |
| IPN045599 | Length 2.5 cm | In distribution |
| IPN040133 | In distribution | |
| IPN045706 | In distribution | |
| IPN047912 | In distribution | |
| IPN915672 | In distribution | |
| IPN040018 | In distribution | |
| IPN045584 | In distribution | |
| IPN040049 | In distribution | |
| IPN045589 | In distribution | |
| IPN046023 | In distribution | |
| IPN925123 | In distribution | |
| IPN045594 | Length 9 cm | In distribution |
| IPN921058 | In distribution | |
| IPN040015 | In distribution | |
| IPN040106 | Length 60 cm | In distribution |
| IPN040024 | In distribution | |
| IPN045602 | In distribution | |
| IPN919748 | In distribution | |
| IPN048024 | In distribution | |
| IPN045747 | Length 60 cm | In distribution |
| IPN040126 | In distribution | |
| IPN040152 | Length 90 cm | In distribution |
| IPN045593 | Length 9 cm | In distribution |
| IPN046023 | In distribution | |
| IPN045583 | In distribution | |
| IPN040201 | In distribution | |
| IPN045580 | Length 60 cm | In distribution |
| IPN040111 | In distribution | |
| IPN040060 | Length 0 cm | In distribution |
| IPN040051 | In distribution | |
| IPN040056 | In distribution | |
| IPN040016 | In distribution | |
| IPN040206 | In distribution | |
| IPN046734 | In distribution | |
| IPN046485 | Length 0 cm | In distribution |
| IPN919735 | In distribution | |
| IPN045585 | Length 60 cm | In distribution |
| IPN048792 | In distribution | |
| IPN046511 | Length 90 cm | In distribution |
| IPN045610 | In distribution | |
| IPN045588 | In distribution | |
| IPN040010 | Length 0 cm | In distribution |
| IPN046020 | In distribution | |
| IPN921132 | In distribution | |
| IPN046019 | In distribution | |
| IPN040132 | Length 0 cm | In distribution |
| IPN040127 | In distribution | |
| IPN045757 | Length 60 cm | In distribution |
| IPN046312 | In distribution | |
| IPN040095 | In distribution | |
| IPN046022 | In distribution | |
| IPN045700 | Length 90 cm | In distribution |
| IPN921049 | In distribution | |
| IPN040053 | In distribution | |
| IPN040000 | In distribution | |
| IPN919732 | In distribution | |
| IPN048794 | In distribution | |
| IPN928780 | In distribution | |
| IPN925030 | In distribution | |
| IPN032604 | In distribution | |
| IPN040002 | Length 5 cm | In distribution |
| IPN928610 | In distribution | |
| IPN045738 | Length 60 cm | In distribution |
| IPN038545 | In distribution | |
| IPN040131 | In distribution | |
| IPN036278 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 1,340 |
| Halyard | Avanos Medical, Inc. | 422 |
| Avanos | Avanos Medical, Inc. | 315 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 215 |
| Integra® | Integra Pain Management | 181 |
| Epilong | Pajunk Gmbh Medizintechnologie | 79 |
| BD Perisafe, BD Epilor, BD Luer-Lok | Becton, Dickinson AND Company | 44 |
| Temena | Temena GmbH | 44 |
| BD Luer-Lok, BD Glaspak | Becton, Dickinson AND Company | 36 |
| Contiplex® | B. Braun Medical Inc. | 34 |
| Stimulong Sono | Pajunk Gmbh Medizintechnologie | 27 |
| Clint Pharmaceuticals | ICU Medical, Inc | 26 |
Showing 12 of 109. All products under Anesthesia Conduction Kit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153652 | 2016-06-21 |
| K121403 | 2012-06-20 |
| K103658 | 2012-05-16 |
Recalls Naming This Product
27 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 | 205,685 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-07-06 | Class II | Incorrect or no expiration date | The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility | 2021-11-05 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-07-06 | Class II | Incorrect or no expiration date | The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility | 2021-11-05 | |
| 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 | 1150 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 | 155 | 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 | 870 | 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 | 160 | 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 | 1760 | 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 | 1320 | 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 | 1360 | 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 | 540 | 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 | 2126 | 2021-02-25 |
| 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 | 2014-11-10 | Class II | Labeling False and Misleading | Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct | 786 | 2016-09-08 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2013-10-09 | Class II | Labeling mix-ups | A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin. | 121 | 2015-09-21 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2011-06-17 | Not classified | Packaging | Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed. | 95 kits | 2012-10-01 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 56,000 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 970 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 14,030 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 9,780 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 100 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 160 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 1,200 units | 2012-09-29 |
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.