medical Class II Updated 2020-04-08

Gentell, Inc recalls Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Un

Recalled Product

Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.


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: 1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1121419 1124919
View official government recall

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