Recalls / —
—#120096
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
- FDA product code
- GWM — Device, Monitoring, Intracranial Pressure
- Device class
- Class 2
- Medical specialty
- Neurology
- Affected lot / code info
- K002765 Lot # 130712, 210912, 220612, 172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942
Why it was recalled
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Timeline
- Recall initiated
- 2013-06-11
- Posted by FDA
- 2013-10-23
- Terminated
- 2014-02-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #120096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.