Recall Z-1422-2010 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
| Date | Apr 20, 2010 (initiated Feb 18, 2010) |
| Status | Terminated |
| Reason | One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center. |
| Root cause | Process control |
| Action | An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter. |
| Quantity | 1 |
| Distribution | One hospital in Omaha, NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040235 | LICOX PMO BRAIN MONITORING SYSTEM Integra LifeSciences Corporation, Apr 20, 2004 |