AMD-Ritmed Transparent Dressing - Window with label recalled over fire hazard

Recall date

June 8, 2016

Source

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

Official notice title

Amd-Ritmed, Inc. recalls AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -…

Recall number

Z-0727-2017

FDA classification

Class II

Brand / firm

Amd-Ritmed, Inc.

Sold / distributed

NY, MA, VA, TN

Why it was recalled

The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.

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

What was recalled

AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150