PhotoMedex, Inc. recalls Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound…

Recall date

March 26, 2015

Source

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

Recall number

Z-1516-2015

FDA classification

Class II

Brand / firm

PhotoMedex, Inc.

Sold / distributed

Nationwide and Internationally, including Canada.

Why it was recalled

The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.

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

What was recalled

Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.