—#127071

Product

Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K131184
Affected lot / code info: Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013

Why it was recalled

Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Integra sent an "Urgent Voluntary Medical Device Recall/Return Response form notifications dated April 16, 2014 to US customers via traceable courrier service and to non-US customers via traceable email or facsimile. The customer notification advises them of the nature of the issue and the potential for adverse patient consequences; advises them to review their inventory and if they have BC10R Test Kit Resistors with an affected lot number to immediately stop using it; requests they identify and report to Integra if they do or do not have any affected BC10R affected lot numbers; and advises them how to return any affected products in their possession. Customers with questions were instructed to call 1-855-532-1723.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution - USA including Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, South Dakota and Internationally to Australia, Austria, Belgium, Chile, Finland, Germany, Great Britain, Greece, Israel, Italy and Russia.

Timeline

Recall initiated: 2014-04-16
Posted by FDA: 2014-05-30
Terminated: 2014-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.