Recall Z-1675-2014— Integra LifeSciences Corp.

Name: FDA recall Z-1675-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-16

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2014-04-16, terminated 2014-10-24. It names one FDA 510(k) clearance: K131184. 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.. Reason: 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)..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Terminated: 2014-10-24
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K131184 — INTEGRA LICOX PTO2 MONITORIntegra Lifesciences Corp.·cleared 2013-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.