NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
FDA device recall Z-0339-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Integra Neuro Sciences
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 79
- Distribution
- Nationwide
- Date initiated
- 2005-09-08
- Date posted
- 2006-01-06
- Date terminated
- 2012-03-07
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 (K050720) | Integra Neurosciences | 2005-05-11 |