FDA-Device2014-08-13Class II
Latex Dental Dams labeled as Non-Latex Dental Dams
Coltene Whaledent Inc
Hazard
Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.
Sold states
Distributed in Memphis, TN.
Affected count
32 boxes, 15 individual dams per box
Manufactured in
235 Ascot Parkway, N/A, Cuyahoga Falls, OH, United States
Products
Latex Dental Dams labeled as Non-Latex Dental Dams
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2151-2014Don't want to check this manually?
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