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Gentell, Inc recalls Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermu
Recalled May 13, 2020 · FDA recall Z-1909-2020 · Gentell
Hazard
During an FDA audit, it was discovered that the product was not properly registered with FDA. · FDA Class II
Units
4,348
Sold at
Worldwide distribution - US Nationwide distributions and the country of South Africa.
Description
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Product
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - 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.
Manufacturer(s)
Gentell, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →