FDA-Device2016-04-06Class II
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
Amd Ritmed
Hazard
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Sold states
US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
Affected count
126 cases total (87 cases domestically and 39 cases internationally)
Manufactured in
1200 Av 55e, N/A, Lachine, N/A, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2016Don't want to check this manually?
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