Argon Medical Devices, Inc recalls (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 0401830…

Recall date

October 16, 2018

Source

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

Recall number

Z-0288-2020

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

(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.