Cardinal Health recalls Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for…

Recall date

August 25, 2015

Source

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

Recall number

Z-0133-2016

FDA classification

Class II

Brand / firm

Cardinal Health

Sold / distributed

Nationwide Distribution.

Why it was recalled

Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.

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

What was recalled

Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.