Argon Medical Devices, Inc recalls ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Intro…

Recall date

June 19, 2020

Source

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

Recall number

Z-2806-2020

FDA classification

Class II

Brand / firm

Argon Medical Devices, Inc

Sold / distributed

US Nationwide distribution including in the state of MS.

Why it was recalled

Sterile introducer sheath set manufactured under one lot with different expiration dates.

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

What was recalled

ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.