Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
FDA device recall Z-2072-2014 · posted 2014-07-17 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
- Action taken
- A customer notification letter dated 7/9/14 was sent to customers to inform them that Integra LifeSciences has recently revised the labeling of certain Camino Intracranial Pressure Monitoring Kits to indicate they are UNSAFE in an MR environment. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the form attached the letter and return it by email or fax. Customers with questions are instructed to contact Customer Service at (855) 532-1723.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- GWN
- Quantity affected
- 28,752 units
- Distribution
- Algeria, Austria, Belgium, Bulgaria, Cyprus, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Luxemborg, Netherland
- Date initiated
- 2014-07-09
- Date posted
- 2014-07-17
- Date terminated
- 2014-10-14
- 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 |
|---|---|---|
| CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C (K102875) | Integra LifeSciences Corporation | 2010-12-20 |