ViaMed Alcohol Prep Pads recalled over sterility concerns

Recall date

February 12, 2025

Source

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

Official notice title

Wuxi Medical lnstrument Factory Co., Ltd. recalls ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Cart…

Recall number

D-0247-2025

FDA classification

Class II

Brand / firm

Wuxi Medical lnstrument Factory Co., Ltd.

Sold / distributed

FL

Why it was recalled

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

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

What was recalled

ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.