RecallRadar

FDA Device recall Z-0201-2015

Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamo…

On 2014-11-19 the FDA classified a Class II recall of Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamo… by Integra Lifesciences, citing 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 dat….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0201-2015
ClassificationClass II
Statusterminated
Initiated2014-08-18
Published2014-11-19
Last updated2026-09-13 11:53 UTC
CompanyIntegra Lifesciences
DistributionCA, DC, FL, IL, IN, MI, MN, NC, NY, PA, TX

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

Reason

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.

Identifiers

code_info
Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 21310…Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0201-2015%22

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