Home / Recalls / Medical Devices
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, B
Recalled July 27, 2016 · FDA recall Z-2213-2016 · Amd-Ritmed
Hazard
The product lot did not meet sterility requirements based on FDA sampling and analysis. · FDA Class II
Units
US: 107 cases (48 rolls per case)
Sold at
US Distribution in states of: NY, CA, and TN.
Description
The product lot did not meet sterility requirements based on FDA sampling and analysis.
Product
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.
Manufacturer(s)
Amd-Ritmed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →