Recall Z-1191-2008 ยท GWM Device, Monitoring, Intracranial Pressure
Integra Neuro Sciences
INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences
| Date | Aug 5, 2008 (initiated Jan 28, 2008) |
| Status | Terminated |
| Reason | Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg. |
| Root cause | Process design |
| Action | Integra NeuroSciences sent a Recall Notification with a Recall Acknowledgement form to all customers with product currently in their possession through an Integra Field Sales Repesentative on January 28, 2008. The notification advises that the firm has determined that due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg that could result in a maximum Insertion Error of +/- 6mmHg. Customers are asked to examine their inventory immediately to det |
| Quantity | 43 units |
| Distribution | USA Distribution: CA, GA, NM, TX, NE, WA, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071505 | MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM Integra LifeSciences Corporation, Aug 6, 2007 |