CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report
The Integra Licox Pt02 Monitors are compact recalled
Integra LifeSciences is recalling The Integra Licox Pt02 Monitors are compact, portable device for use with. The recall was initiated on 14 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1620-2015
- FDA event ID
- 71027
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Apr 2015
- FDA classified
- 15 May 2015
- Reported
- 27 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 14 Apr 2015 | Recall initiated by company | |
| 15 May 2015 | Classified by FDA | +31 days |
| 27 May 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Is The Integra Licox Pt02 Monitors are compact, portable device for use with recalled?
Yes. Integra LifeSciences recalled The Integra Licox Pt02 Monitors are compact, portable device for use with on 14 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1620-2015.
Why was it recalled?
Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
Which lots are affected?
All Lots
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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