Argon Medical Devices Hemostasis Valve recalled over sterility concerns

Recall date

October 16, 2018

Source

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

Official notice title

Argon Medical Devices, Inc recalls Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 25…

Recall number

Z-0294-2020

FDA classification

Class II

Brand / firm

Argon Medical Devices, Inc

Sold / distributed

Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.

Why it was recalled

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

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

What was recalled

Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.