Nov

2014

Cl II Integra Licox Pt02 Monitor

Company: Integra LifeSciences Corp.
Date of Enforcement Report 11/19/2014
Class lI:

PRODUCT

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
Recall Number Z-0201-2015

REASON
ntegra 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.

RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp., Plainsboro, NJ on 8/18/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,519 units total (403 units total)

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Integra Licox Pt02 Monitor

Amy Sellers

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