Recall Z-0563-2022— Argon Medical Devices, Inc

Name: FDA recall Z-0563-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-24

Class II · Ongoing

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2022-01-24. It names one FDA 510(k) clearance: K780871. Product: 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6". Reason: Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-01-24
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

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Reason for recall

Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

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