Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
FDA Recall Z-1422-2010 · Posted 2010-04-20
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeGWM
Date Initiated2010-02-18
Date Terminated2010-04-20
Product Quantity1
Reason for Recall
One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
Firm Action
An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.
Root Cause
Process control
Distribution Pattern
One hospital in Omaha, NE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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