—#89131

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.

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K040235
Affected lot / code info: Catalog number CC1P1, Serial number SN 776; Lot number 160110A

Why it was recalled

One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.

Root cause (FDA determination)

Process control

Action the firm took

An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.

Recalling firm

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

Distribution

Distribution pattern: One hospital in Omaha, NE.

Timeline

Recall initiated: 2010-02-18
Posted by FDA: 2010-04-20
Terminated: 2010-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.