Recall Z-1936-2020— Argon Medical Devices, Inc

Name: FDA recall Z-1936-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-08

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2020-04-08, terminated 2022-12-14. It names one FDA 510(k) clearance: K780871. 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. Reason: 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..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-04-08
Terminated: 2022-12-14
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K780871 — ARTERIAL LINE KITArgon Medical Corp.·cleared 1978-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.