Argon Medical Devices, Inc recalls PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The int…

Recall date

April 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1938-2020

FDA classification

Class II

Brand / firm

Argon Medical Devices, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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