# Arrow IPN037693 > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Teleflex Incorporated](https://devicerts.com/manufacturers/teleflex-incorporated) (FDA registration: United States) - Name in the registry: ARROW IPN037693 - Device class: Class II (US FDA) - FDA product code: FOZ - GMDN: Epidural anaesthesia set, non-medicated (34842) ## Registrations and authorizations - **GUDID** · GUDID listing · United States · UDI-DI 10801902130423 · listed 2017-11-30 · status: Listed (GUDID: in commercial distribution) - **GUDID** · FDA 510(k) · United States · K071538 · decision 2007-08-30 · decision SESE · status: Active · from GUDID ## Recalls - Z-2376-2026 · Class I · ongoing · initiated 2026-04-21 · matched through shared submission K071538, may concern other models: 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-based injectable product is compromised this could lead to serious or life-threatening injuries. - Z-1914-2026 · Class II · ongoing · initiated 2026-03-11: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured - Z-2123-2026 · Class II · ongoing · initiated 2026-01-07: 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 the potential to impact the sterility assurance level (SAL) of the Recalled Products. - Z-0003-2024 · Class I · ongoing · initiated 2023-08-10: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. - Z-0002-2024 · Class I · ongoing · initiated 2023-08-10: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. - Z-0352-2023 · Class I · terminated · initiated 2022-10-27: 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 Three-Lumen CVC Kit. - Z-0351-2023 · Class I · terminated · initiated 2022-10-27: 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 Three-Lumen CVC Kit. - Z-1604-2022 · Class II · ongoing · initiated 2022-05-25: 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. - Z-2000-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1994-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1997-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1995-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1987-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1991-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1993-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1992-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1996-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1990-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1980-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1981-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1988-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1998-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1989-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1999-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1979-2018 · Class II · terminated · initiated 2018-04-11: Product sterility may be compromised due to unsealed packaging. - Z-1326-2018 · Class II · terminated · initiated 2017-12-22: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. - Z-0995-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-0998-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-1005-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-0997-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-0994-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-1004-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-1003-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-0999-2018 · Class II · terminated · initiated 2017-11-27: 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. - Z-1163-2018 · Class II · terminated · initiated 2017-11-14: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. - Z-1162-2018 · Class II · terminated · initiated 2017-11-14: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. - Z-1164-2018 · Class II · terminated · initiated 2017-11-14: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. - Z-1166-2018 · Class II · terminated · initiated 2017-11-14: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. - Z-1159-2018 · Class II · terminated · initiated 2017-11-14: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. - Z-1161-2018 · Class II · terminated · initiated 2017-11-14: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. - Z-1165-2018 · Class II · terminated · initiated 2017-11-14: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. - Z-0651-2018 · Class II · terminated · initiated 2017-10-17: These finished good kits may contain the incorrect Springwire Guide (SWG). - Z-0655-2018 · Class II · terminated · initiated 2017-10-17: These finished good kits may contain the incorrect Springwire Guide (SWG). - Z-0649-2018 · Class II · terminated · initiated 2017-10-17: These finished good kits may contain the incorrect Springwire Guide (SWG). - Z-0653-2018 · Class II · terminated · initiated 2017-10-17: These finished good kits may contain the incorrect Springwire Guide (SWG). - Z-0647-2018 · Class II · terminated · initiated 2017-10-17: These finished good kits may contain the incorrect Springwire Guide (SWG). - Z-2330-2017 · Class II · terminated · initiated 2017-05-09: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. - Z-1879-2017 · Class II · terminated · initiated 2017-03-17: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover. - Z-2136-2016 · Class II · terminated · initiated 2016-06-02: Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit. - Z-1082-2015 · Class II · terminated · initiated 2015-01-02: Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user. - Z-1005-2015 · Class II · terminated · initiated 2014-12-16: the Instructions for Use (IFU) were inadvertently removed from the kit. - Z-1633-2014 · Class II · terminated · initiated 2013-07-17: The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r - Z-1823-2012 · Class II · terminated · initiated 2012-06-07: Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover. - Z-2491-2010 · · terminated · initiated 2010-07-29: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle ## Identity - Trade name: ARROW [FDA GUDID (AccessGUDID)] - Generic name: Epidural anaesthesia set, non-medicated [FDA GUDID (AccessGUDID)] - Model / Ref / Catalog: IPN037693 [FDA GUDID (AccessGUDID)]; ASK-45854-PECL1 [FDA GUDID (AccessGUDID)] ## Identifiers - Primary DI / UDI-DI: 10801902130423 [FDA GUDID (AccessGUDID)] - 510(k) Number: K071538 [FDA GUDID (AccessGUDID)] - FDA product code: FOZ [FDA GUDID (AccessGUDID)] - GMDN term: Epidural anaesthesia set, non-medicated (34842) [FDA GUDID (AccessGUDID)] ## Classification - Device class: Class II [FDA GUDID (AccessGUDID)] - Regulation number: 880.5200 [FDA GUDID (AccessGUDID)] - GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)] ## Properties - Supplied sterile: Yes [FDA GUDID (AccessGUDID)] - Single use: Yes [FDA GUDID (AccessGUDID)] - Prescription use: Yes [FDA GUDID (AccessGUDID)] - Convenience kit: Yes [FDA GUDID (AccessGUDID)] - Combination product: Yes [FDA GUDID (AccessGUDID)] - Lot / batch number: Yes [FDA GUDID (AccessGUDID)] - Expiration date: Yes [FDA GUDID (AccessGUDID)] - Manufacturing date: Yes [FDA GUDID (AccessGUDID)] - Sterilise before use: No [FDA GUDID (AccessGUDID)] - Implantable: No [FDA GUDID (AccessGUDID)] - Contains latex: No [FDA GUDID (AccessGUDID)] - Over-the-counter: No [FDA GUDID (AccessGUDID)] - HCT/P: No [FDA GUDID (AccessGUDID)] - Premarket exempt: No [FDA GUDID (AccessGUDID)] - Serial number: No [FDA GUDID (AccessGUDID)] ## Source and citation - Cite as: Arrow IPN037693, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/arrow-ask-45854-pecl1 (data as of 2026-11-14). - Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-23 - Statuses computed as of: 2026-11-14 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/arrow-ask-45854-pecl1 - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.