Arrow IPN037693

• FDA 510(k) K071538 decided 30 Aug 2007 Active
• FDA GUDID UDI-DI 10801902130423 listed 30 Nov 2017 Listed

• • Ongoing Z-2376-2026 FDA Class I ·initiated 21 Apr 2026 ·on shared 510(k) K071538

  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.

• • Ongoing Z-1914-2026 FDA Class II ·initiated 11 Mar 2026

  Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

• • Ongoing Z-2123-2026 FDA Class II ·initiated 7 Jan 2026

  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.

• 2 recalls, same reason

  • Ongoing Z-0003-2024 FDA Class I ·initiated 10 Aug 2023
  • Ongoing Z-0002-2024 FDA Class I ·initiated 10 Aug 2023

  This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

• • Ongoing Z-1604-2022 FDA Class II ·initiated 25 May 2022

  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.

• 2 recalls, same reason

  • Terminated Z-0352-2023 FDA Class I ·initiated 27 Oct 2022
  • Terminated Z-0351-2023 FDA Class I ·initiated 27 Oct 2022

  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.

• 17 recalls, same reason

  • Terminated Z-2000-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1994-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1997-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1995-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1987-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1991-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1993-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1992-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1996-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1990-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1980-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1981-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1988-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1998-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1989-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1999-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1979-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1326-2018 FDA Class II ·initiated 22 Dec 2017

  Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

• 8 recalls, same reason

  • Terminated Z-0995-2018 FDA Class II ·initiated 27 Nov 2017
  • Terminated Z-0998-2018 FDA Class II ·initiated 27 Nov 2017
  • Terminated Z-1005-2018 FDA Class II ·initiated 27 Nov 2017
  • Terminated Z-0997-2018 FDA Class II ·initiated 27 Nov 2017
  • Terminated Z-0994-2018 FDA Class II ·initiated 27 Nov 2017
  • Terminated Z-1004-2018 FDA Class II ·initiated 27 Nov 2017
  • Terminated Z-1003-2018 FDA Class II ·initiated 27 Nov 2017
  • Terminated Z-0999-2018 FDA Class II ·initiated 27 Nov 2017

  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.

• 7 recalls, same reason

  • Terminated Z-1163-2018 FDA Class II ·initiated 14 Nov 2017
  • Terminated Z-1162-2018 FDA Class II ·initiated 14 Nov 2017
  • Terminated Z-1164-2018 FDA Class II ·initiated 14 Nov 2017
  • Terminated Z-1166-2018 FDA Class II ·initiated 14 Nov 2017
  • Terminated Z-1159-2018 FDA Class II ·initiated 14 Nov 2017
  • Terminated Z-1161-2018 FDA Class II ·initiated 14 Nov 2017
  • Terminated Z-1165-2018 FDA Class II ·initiated 14 Nov 2017

  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.

• 5 recalls, same reason

  • Terminated Z-0651-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0655-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0649-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0653-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0647-2018 FDA Class II ·initiated 17 Oct 2017

  These finished good kits may contain the incorrect Springwire Guide (SWG).

• • Terminated Z-2330-2017 FDA Class II ·initiated 9 May 2017

  Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

• • Terminated Z-1879-2017 FDA Class II ·initiated 17 Mar 2017

  Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.

• • Terminated Z-2136-2016 FDA Class II ·initiated 2 Jun 2016

  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.

• • Terminated Z-1082-2015 FDA Class II ·initiated 2 Jan 2015

  Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

• • Terminated Z-1005-2015 FDA Class II ·initiated 16 Dec 2014

  the Instructions for Use (IFU) were inadvertently removed from the kit.

• • Terminated Z-1633-2014 FDA Class II ·initiated 17 Jul 2013

  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

• • Terminated Z-1823-2012 FDA Class II ·initiated 7 Jun 2012

  Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.

• • Terminated Z-2491-2010 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010

  Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 11 Apr 2018 Recall initiated FDA recalls Z-1999-2018
2. 11 Apr 2018 Recall initiated FDA recalls Z-1979-2018
3. 25 May 2022 Recall initiated FDA recalls Z-1604-2022
4. 27 Oct 2022 Recall initiated FDA recalls Z-0352-2023
5. 27 Oct 2022 Recall initiated FDA recalls Z-0351-2023
6. 10 Aug 2023 Recall initiated FDA recalls Z-0003-2024
7. 10 Aug 2023 Recall initiated FDA recalls Z-0002-2024
8. 7 Jan 2026 Recall initiated FDA recalls Z-2123-2026
9. 11 Mar 2026 Recall initiated FDA recalls Z-1914-2026
10. 21 Apr 2026 Recall initiated FDA recalls Z-2376-2026

46 earlier events are in the sections above.

Trade name

Arrow

Generic name

Epidural anaesthesia set, non-medicated

Model / Ref / Catalog

IPN037693, ASK-45854-PECL1

Primary DI / UDI-DI

10801902130423

510(k) Number

K071538 ↗

FDA product code

FOZ

GMDN term

Epidural anaesthesia set, non-medicated

Device class

Class II

Regulation number

880.5200

GUDID distribution status

In Commercial Distribution

Category: Epidural anaesthesia set, non-medicated

Other devices filed under FDA product code FOZ (Catheter,intravascular,therapeutic,short-term less than 30 days).

• JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL by Critikon Company, LLC
• 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE by Bd
• Health Line CT Midline Catheter by Health Line International Corp
• INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS by Becton Dickinson Infusion Therapy Systems Inc.
• LANDMARK ADD-A-LUMEN CATHETER KIT by Menlo Care, Inc.
• ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE by Arrow Intl., Inc.
• ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER by Arrow International, Inc.
• BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX by Bioteque Corp.
• FIRST PICC CATHETER by Becton Dickinson Infusion Therapy Systems Inc.
• CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS by Sims Deltec, Inc.

• Arrow IPNB00820 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00826 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00822 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00827 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

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