Z-1422-2010

Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain...

Name: Z-1422-2010 Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain...
Creator: Integra LifeSciences Corp.
Published: 2010-02-18
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-02-18 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2010-02-18. The reason FDA records is "One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1422-2010
Status: Terminated
Initiated: 2010-02-18
Posted: 2010-04-20
Terminated: 2010-04-20
Recalling firm: Integra LifeSciences Corporation
Product: 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.
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.
Quantity in commerce: 1
Distribution: One hospital in Omaha, NE.
Product codes and lots: Catalog number CC1P1, Serial number SN 776; Lot number 160110A

Product code GWM

K040235Class IILicox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation / cleared 2004-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)