NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
This recall has been terminated (originally issued January 6, 2006).
- Company
- Integra Neuro Sciences
- Recall Initiated
- September 8, 2005
- Posted
- January 6, 2006
- Terminated
- March 7, 2012
- Recall Number
- Z-0339-06
- Quantity
- 79
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
W050708, W050980, & W050997
Root Cause
Other
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.
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