FDA-Device2014-11-19Class II
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Integra LifeSciences Corp.
Hazard
Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.
Sold states
US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX
Affected count
43 (LCX02) and 17 (LCX02R)
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2015Don't want to check this manually?
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