Product Wiki · Recalls · U.S. FDA — Device Enforcement

Latex Dental Dams labeled as Non-Latex Dental Dams — recall Z-2151-2014

U.S. FDA — Device Enforcement · United States · 2013-12-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2151-2014
Date of alert
2013-12-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Coltene Whaledent Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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