Gentell Hydrogel Ag Saturated Gauze recalled over manufacturing violations

Recall date

December 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Gentell, Inc recalls Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufa…

Recall number

D-0242-2017

FDA classification

Class II

Brand / firm

Gentell, Inc

Sold / distributed

United States

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007