Gentell, Inc recalls Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptosperm…

Recall date

March 26, 2020

Source

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

Recall number

Z-1908-2020

FDA classification

Class II

Brand / firm

Gentell, Inc

Sold / distributed

Worldwide distribution - US Nationwide distributions and the country of South Africa.

Why it was recalled

During an FDA audit, it was discovered that the product was not properly registered with FDA.

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

What was recalled

Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions