Recall Z-0339-06 ยท GWM Device, Monitoring, Intracranial Pressure
Integra Neuro Sciences
NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
| Date | Jan 6, 2006 (initiated Sep 8, 2005) |
| Status | Terminated |
| Reason | Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring. |
| Root cause | Other |
| Action | Notify Customers and Sales Representatives who received the product by letter sent via Federal Express. Customers will be instructed that an Integra Sales Representative will contact them to arrange for return of affected product. |
| Quantity | 79 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050720 | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 Integra Neurosciences, May 11, 2005 |