NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit 의 리콜

Recall

33451

Class 2

Z-0339-06

2005-09-08

2006-01-06

Terminated

United States

2012-03-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41902

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.

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.