Reported Nov 19, 2014 · Terminated

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

Integra LifeSciences Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344

Is this the product you have?

  • Integra Licox Pt02 Monitor, Rx Only
  • ManufacturerIntegra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland
  • Distributed byIntegra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Lot codes and dates
    • 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
Amount recalled
43 (LCX02) and 17 (LCX02R)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 11, 2016 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.