Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit

FDA Recall Z-0339-06 · Posted 2006-01-06

Recalling FirmIntegra Neuro Sciences
Recall StatusTerminated
Product CodeGWM
Date Initiated2005-09-08
Date Terminated2012-03-07
Product Quantity79

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050720NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100Integra Neurosciences · 2005-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑