medical Class II Updated 2020-05-20

Argon Medical Devices, Inc recalls Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 11299236
View official government recall

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