Arrow Percutaneous Sheath Introducer Kit Ak-07903

• • Ongoing Z-2385-2026 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.

• 4 recalls, same reason

  • Terminated Z-2017-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2018-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1975-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1986-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1334-2018 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-1160-2018 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.

• • Terminated Z-0784-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009

  Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.

• • Terminated Z-1492-2009 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.

• • Terminated Z-1035-03 FDA Unclassified (pre-2012) ·initiated 8 Jul 2003 ·on shared 510(k) K940079

  separation of sheath

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

510(k) Number

K940079 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  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

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