Argon Medical Devices, Inc recalls Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC…

Recall date

May 11, 2017

Source

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

Recall number

Z-2252-2017

FDA classification

Class II

Brand / firm

Argon Medical Devices, Inc

Sold / distributed

Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands

Why it was recalled

Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.

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

What was recalled

Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.