Argon Medical Devices, Inc: Medical Device Recall in 2020 - (Recall #: Z-1936-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit 20ga x 3", Ref 498411B, Qty: 10/CS

Product Classification:

Class II

Date Initiated: April 8, 2020

Date Posted: May 20, 2020

Recall Number: Z-1936-2020

Event ID: 85488

Reason for Recall:

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.

Status: Terminated

Product Quantity: 150

Code Information:

Lot: 11299236

Distribution Pattern:

US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated