The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Part
FDA device recall Z-1620-2015 · posted 2015-05-15 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
- Action taken
- Integra initiated this recall by sending an Urgent Voluntary Medical Device Recall Letter/Recall Acknowledgement Form dated 4/14/15 via traceable courier service to their affected customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 59 monitors
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-04-14
- Date posted
- 2015-05-15
- Date terminated
- 2017-12-12
- 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 |
|---|---|---|
| INTEGRA LICOX PTO2 MONITOR (K131184) | Integra Lifesciences Corp. | 2013-08-30 |
| INTEGRA CAMINO ICP MONITOR (K121573) | Intrgra Lifesciences Corporation | 2012-09-10 |