Home / Recalls / Medical Devices
Gentell, Inc recalls Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydro
Recalled April 8, 2020 · FDA recall Z-1624-2020 · Gentell
Hazard
During an FDA audit, it was discovered that the product was not properly registered with FDA. · FDA Class II
Units
20,025
Sold at
Worldwide distribution US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.
Description
During an FDA audit, it was discovered that the product was not properly registered with FDA.
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.
Manufacturer(s)
Gentell, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →