FDA-Device2016-11-23Class II
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
C.R. Bard, Inc.
Hazard
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Sold states
U.S. Nationwide.
Affected count
75,089 units
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0406-2017Don't want to check this manually?
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