Argon Medical Devices, Inc: Medical Device Recall in 2020 - (Recall #: Z-1938-2020)

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:

PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for contralateral access to the iliac artery and selected vasculature. Case Label: PAC Tray/5 Catheter Introducer Tray 8F, QTY 10/Bx, Rx Only, STERILE EO

Product Classification:

Class II

Date Initiated: April 8, 2020

Date Posted: May 20, 2020

Recall Number: Z-1938-2020

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: 80

Code Information:

Lot: 11299245

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated