Argon Medical Devices, Inc recalls Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: T…

Recall date

April 26, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2109-2020

FDA classification

Class II

Brand / firm

Argon Medical Devices, Inc

Sold / distributed

International distribution to the countries of China, Taiwan.

Why it was recalled

Tungsten coils of the guidewire included in the introducer kit were detaching.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.