Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesells
FDA device recall Z-0060-2014 · posted 2013-10-23 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- 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.
- Action taken
- Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 42 Kits non US
- 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.
- Date initiated
- 2013-06-11
- Date posted
- 2013-10-23
- Date terminated
- 2014-02-18
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LICOX PMO BRAIN MONITORING SYSTEM (K040235) | Integra LifeSciences Corporation | 2004-04-20 |