Class 2 Device Recall Integra NeuroSensor

• Date Initiated by Firm: January 28, 2008
• Date Posted: August 05, 2008
• Recall Status: Terminated on April 22, 2010
• Recall Number: Z-1191-2008
• Recall Event ID: 46788
• 510(K)Number: K071505
• Product Classification: intracranial pressure probe - Product Code GWM
• Product: INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences
• Code Information: Lot 100063, all serial numbers
• Recalling Firm/ Manufacturer: Integra Neuro Sciences; 5955 Pacific Center Blvd; San Diego CA 92121-4309
• For Additional Information Contact: John Spampinato; 858-455-1115
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 43 units
• Distribution: USA Distribution: CA, GA, NM, TX, NE, WA, and NY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GWM