FDA-Device2025-07-02Class I
Extended Tip Applicator, 8CM, Box of 5.
Integra LifeSciences Corp. (NeuroSciences)
Hazard
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Sold states
Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.
Affected count
6,216 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
Extended Tip Applicator, 8CM, Box of 5.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1958-2025Don't want to check this manually?
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