Arrow Radial Artery Catheterization Set

• • Ongoing Z-2397-2026 FDA Class I ·initiated 21 Apr 2026

  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-3299-2024 FDA Class II ·initiated 26 Jul 2024

  Reports have been received regarding open seals on the packaging.

• • Ongoing Z-0844-2020 FDA Class II ·initiated 12 Dec 2019

  The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit

• 6 recalls, same reason

  • Terminated Z-1971-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1972-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1969-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1970-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1968-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2019-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1330-2018 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.

• 6 recalls, same reason

  • Terminated Z-1284-2018 FDA Class II ·initiated 26 Oct 2017
  • Terminated Z-1285-2018 FDA Class II ·initiated 26 Oct 2017
  • Terminated Z-1286-2018 FDA Class II ·initiated 26 Oct 2017
  • Terminated Z-1283-2018 FDA Class II ·initiated 26 Oct 2017
  • Terminated Z-1282-2018 FDA Class II ·initiated 26 Oct 2017
  • Terminated Z-1281-2018 FDA Class II ·initiated 26 Oct 2017

  The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

• • Terminated Z-0486-2018 FDA Class II ·initiated 10 Jul 2017 ·on shared 510(k) K810675

  Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.

• • Terminated Z-2327-2017 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.

• 2 recalls, same reason

  • Terminated Z-2740-2016 FDA Class II ·initiated 8 Aug 2016
  • Terminated Z-2741-2016 FDA Class II ·initiated 8 Aug 2016

  Shipping carton labeling error.

• 2 recalls, same reason

  • Terminated Z-2201-2016 FDA Class II ·initiated 2 Jun 2016
  • Terminated Z-2202-2016 FDA Class II ·initiated 2 Jun 2016

  Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.

• • Terminated Z-0066-2015 FDA Class II ·initiated 6 Aug 2014 ·on shared 510(k) K810675

  The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.

• 7 recalls, same reason

  • Terminated Z-1359-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1357-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1356-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1355-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1346-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1360-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1358-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010

  Sterility may be compromised.

• 2 recalls, same reason

  • Terminated Z-2495-2010 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010
  • Terminated Z-2494-2010 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.

510(k) Number

K810675 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  FDA 510(k) K040802 Active Cleared 28 Apr 2004

• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

See all devices from Arrow Intl., Inc. →