Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
FDA Recall Z-2072-2014 · Posted 2014-07-17
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeGWN
Date Initiated2014-07-09
Date Terminated2014-10-14
Product Quantity28,752 units
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.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
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, Tunisia, Turkey, United Arab Emirates, Argentina, Brazil, Brunei, Chile, China, India, Japan, Korea, Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.