INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences
This recall has been terminated (originally issued August 5, 2008).
- Company
- Integra Neuro Sciences
- Recall Initiated
- January 28, 2008
- Posted
- August 5, 2008
- Terminated
- April 22, 2010
- Recall Number
- Z-1191-2008
- Quantity
- 43 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
USA Distribution: CA, GA, NM, TX, NE, WA, and NY.
Lot / Code Info
Lot 100063, all serial numbers
Root Cause
Process design
Action Taken
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 determine if they have any NeuroSensor Model NS-P's lot #100063 on hand and if so to not use the product. Customers are advised to contact their local Integra representative for further assistance. The letter advises that the lot/serial number is located on a white 1/2" x 1/2" label on the large beige optical connector, and can readily be seen through the bottom of the product tray packaging. The letter also advises that this recall pertains to NeuroSensor Model NS-P's, lot # 100063 -all serial numbers. A response form is included. In addition, the Field Sales Representatives have been instructed to physically remove all lot 100063 of NeuroSensor Probes from inventory and provide replacement product.