Recall Z-0201-2015 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
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
| Date | Nov 10, 2014 (initiated Aug 18, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Integra LifeSciences sent an "Urgent Voluntary Medical Device Correction" letter/Return Response Form dated August 18, 2014, to their affected customers via traceable courier service. The letter identified the product the problem and the action needed to be taken by the customer. Complete the attached form. If you do not have an affected monitor, check the box: I do not have any monitors with an affected Serial Number listed below. If you do have affected monitors, check the box: I do have monitors with an affected Serial Number listed below. Circle all the Serial Numbers for the affected |
| Quantity | 43 (LCX02) and 17 (LCX02R) |
| Distribution | US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131184 | INTEGRA LICOX PTO2 MONITOR Integra Lifesciences Corp., Aug 30, 2013 |