FDA recall Z-1937-2020

Argon Medical Devices, Inc · Class II · device

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

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-04-08
Report date
2020-05-20
Termination date
2022-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1937-2020