Recall Z-2072-2014 ยท GWN Nystagmograph
Integra LifeSciences Corp.
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
| Date | Jul 17, 2014 (initiated Jul 9, 2014) |
| Status | Terminated |
| Reason | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 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, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tuni |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102875 | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C Integra LifeSciences Corporation, Dec 20, 2010 |