Arrow Jugular Puncture Kit 16 Ga.

• • Ongoing Z-2377-2026 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.

• • Terminated Z-1243-2020 FDA Class II ·initiated 20 Dec 2019

  Product lidstock contains the incorrect expiration date for the product

• • Terminated Z-1974-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1331-2018 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.

• • Terminated Z-2328-2017 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.

• 5 recalls, same reason

  • Terminated Z-1349-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1347-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1345-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1344-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010
  • Terminated Z-1348-2011 FDA Unclassified (pre-2012) ·initiated 29 Oct 2010

  Sterility may be compromised.

• • Terminated Z-1494-2009 FDA Unclassified (pre-2012) ·initiated 11 Feb 2009

  Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

510(k) Number

K820009 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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

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  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

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  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. →

• What is the Arrow Jugular Puncture Kit 16 Ga. used for?

  The Arrow Jugular Puncture Kit 16 Ga. is designed for percutaneous access to the jugular vein, enabling clinicians to perform vascular access procedures by introducing a needle or catheter through the skin into the vein.

• How is the Arrow Jugular Puncture Kit 16 Ga. supplied?

  The device is supplied as a complete kit for clinical use, containing the necessary components for percutaneous jugular vein access, though specific kit contents are not detailed in the provided data.

• What regulatory pathway was used for the Arrow Jugular Puncture Kit 16 Ga.?

  The Arrow Jugular Puncture Kit 16 Ga. received FDA 510(k) clearance under number K820009 on January 22, 1982, following a traditional review process, which determined it to be substantially equivalent to a predicate device.