Amd-Ritmed, Inc. recalls AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606,…

Recall date

March 30, 2016

Source

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

Recall number

Z-2213-2016

FDA classification

Class II

Brand / firm

Amd-Ritmed, Inc.

Sold / distributed

US Distribution in states of: NY, CA, and TN.

Why it was recalled

The product lot did not meet sterility requirements 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 brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.