BEUDAMED
    FDA Enforcement Class II Terminated

    X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

    Recall: Z-2207-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2207-2014
    Event ID
    68788
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gambro Renal Products, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 20, 2014
    Initiation Date
    July 18, 2014
    Classification Date
    August 13, 2014
    Termination Date
    February 5, 2015
    Address
    14143 Denver West Pkwy, N/A, Lakewood, CO, 80401-3266, United States

    Description

    X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

    Reason

    Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

    Code Info

    Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017

    Distribution

    Worldwide Distribution.

    Quantity

    401,451