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Argon Medical Devices, Inc recalls Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters
Recalled May 20, 2020 · FDA recall Z-1937-2020 · Argon Medical Devices
Hazard
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. · FDA Class II
Units
20
Sold at
US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
Description
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.
Product
Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - 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/1 20ga x 3", Qty: 10/CS, CE 2797
Manufacturer(s)
Argon Medical Devices, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →