BEUDAMED
    FDA Recall Terminated

    Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L

    Recall: Z-2072-2014 · Initiated July 9, 2014

    Recall

    Recall Number
    Z-2072-2014
    Event Number
    68742
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GWN
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 9, 2014
    Posted
    July 17, 2014
    Terminated
    October 14, 2014
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L

    Reason

    Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.

    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.

    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, Tunisia, Turkey, United Arab Emirates, Argentina, Brazil, Brunei, Chile, China, India, Japan, Korea, Mexico.

    Quantity

    28,752 units