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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 08, 2005
Date Posted January 06, 2006
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-0339-06
Recall Event ID 33451
510(K)Number K050720  
Product Classification Device, Monitoring, Intracranial Pressure - Product Code GWM
Product NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
Code Information W050708, W050980, & W050997
Recalling Firm/
Manufacturer		 Integra Neuro Sciences
5955 Pacific Center Blvd
San Diego CA 92121-4309
For Additional Information Contact Eduardo Blanco
858-455-1115 Ext. 115
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 79
Distribution Nationwide
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 and Original Applicant = INTEGRA NEUROSCIENCES
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