Amd Ritmed recalls IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5…

Recall date

February 24, 2016

Source

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

Recall number

Z-1251-2016

FDA classification

Class II

Brand / firm

Amd Ritmed

Sold / distributed

US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.

Why it was recalled

Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.

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

What was recalled

IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities