Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe
FDA device recall Z-0831-2015 · posted 2014-12-18 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.
- Action taken
- Integra sent Urgent- Voluntary Medical Device Recall Letters/Recall Acknowledgement and Return Form dated 11/7/2014 to customers and distributors via traceable courier service.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 2,506 units
- Distribution
- Nationwide, Foreign
- Date initiated
- 2014-11-07
- Date posted
- 2014-12-18
- Date terminated
- 2015-08-11
- 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 IT2 COMPLETE BRAIN TUNNELING PROBE KIT (K053244) | Integra Lifesciences Corp. | 2006-05-10 |
| LICOX PMO BRAIN MONITORING SYSTEM (K040235) | Integra LifeSciences Corporation | 2004-04-20 |
| LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE (K002765) | Integra Neurosciences | 2000-11-24 |