Recall Z-0061-2014 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU 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.
| Date | Oct 23, 2013 (initiated Jun 11, 2013) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile. |
| Quantity | 695 units (US and Foreign) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040235 | LICOX PMO BRAIN MONITORING SYSTEM Integra LifeSciences Corporation, Apr 20, 2004 |