Argon Medical Devices, Inc recalls HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens

Recall date

January 18, 2017

Source

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

Recall number

Z-1196-2017

FDA classification

Class II

Brand / firm

Argon Medical Devices, Inc

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.

Why it was recalled

The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

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

What was recalled

HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens