Food, drugs, devices › Integra LifeSciences Corp.
Device recall: Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology P
Integra LifeSciences Corp. (Plainsboro, NJ) initiated this device recall on 18 Aug 2014; FDA lists 1 product record under event 69251, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 11 May 2016. Initiation: voluntary: firm initiated. Integra LifeSciences Corp. has 79 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra LifeSciences Corp., Plainsboro, NJ.
Reason for recall
"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."
Distribution
"US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0201-2015 | 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 | 43 (LCX02) and 17 (LCX02R) | Class II | Terminated | 19 Nov 2014 |
Context
Other enforcement events for Integra LifeSciences Corp.
All 79 events for Integra LifeSciences Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.