medical Class II Updated 2020-05-13

Gentell, Inc recalls Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wo

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 1133718 1135318 1101019 1102819 1105819 1107119 1110619 1116219 1118219 1121119 1122119 1123519 1126319 1130319
View official government recall

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