Gentell, Inc recalls Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage
Recalled Product
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze 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
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