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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description 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.
Recall Number Z-1675-2014
Classification Class II
Code Info Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013
Product Distributed Qty 49 test probes
Reason For Recall 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).

Event Detail

Event Id 68159
Product Type Devices
Status Ongoing
Recalling Firm Integra LifeSciences Corp.
City Plainsboro
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-16
Initial Firm Notification of Consignee or Public Letter
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.