Recall Z-2501-2021— Argon Medical Devices, Inc

Name: FDA recall Z-2501-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-08

Class II · Ongoing

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2021-07-08. It names one FDA 510(k) clearance: K202141. Product: Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.. Reason: As a result of design changes, sheaths have exhibited cracking/breaking at the tips..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-07-08
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K202141 — Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc.·cleared 2021-01-15

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

Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

Reason for recall

As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

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