Arterial Line Kit

• • Ongoing Z-2708-2026 FDA Class I ·initiated 1 Jun 2026

  Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

• • Ongoing Z-0563-2022 FDA Class II ·initiated 24 Jan 2022

  Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

• 2 recalls, same reason

  • Terminated Z-1937-2020 FDA Class II ·initiated 8 Apr 2020
  • Terminated Z-1936-2020 FDA Class II ·initiated 8 Apr 2020

  Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

• 7 recalls, same reason

  • Terminated Z-1745-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010 ·on shared 510(k) K780871
  • Terminated Z-1743-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010 ·on shared 510(k) K780871
  • Terminated Z-1744-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010 ·on shared 510(k) K780871
  • Terminated Z-1741-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010 ·on shared 510(k) K780871
  • Terminated Z-1737-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010
  • Terminated Z-1742-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010 ·on shared 510(k) K780871
  • Terminated Z-1740-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010

  There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

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

510(k) Number

K780871 ↗

FDA Product Code

GDY

Device Class

Class I

Regulation

21 CFR Part 878.4450

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• V-Stick Vascular Access Set

  Class II

  FDA 510(k) K130730 Active Cleared 22 Nov 2013

• Digicath

  Class II

  FDA 510(k) K831171 Active Cleared 25 May 1983

• Central Catheter Kit

  Class II

  FDA 510(k) K780673 Active Cleared 16 May 1978

• Argon Dual Lumen Hemodialysis, Catheter

  Class II

  FDA 510(k) K842039 Active Cleared 29 Jan 1985

• Translumbar Aortography Needle Catheter

  Class II

  FDA 510(k) K884375 Active Cleared 11 Jan 1989

• Introducer for Ptca Guiding Catheters

  Class II

  FDA 510(k) K891022 Active Cleared 19 May 1989

See all devices from Argon Medical Corp. →