BEUDAMED
    FDA Enforcement Class II Terminated

    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box

    Recall: Z-2194-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2194-2014
    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

    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box

    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

    Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.

    Distribution

    Worldwide Distribution.

    Quantity

    401,451