Argon Medical Devices, Inc recalls Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheter…

Recall date

April 8, 2020

Source

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

Recall number

Z-1936-2020

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

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