BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2207-2014 · Initiated July 18, 2014

    Recall

    Recall Number
    Z-2207-2014
    Event Number
    68788
    Firm
    Gambro Renal Products, Incorporated
    FEI Number
    1713683
    Product Code
    FLD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 18, 2014
    Posted
    August 13, 2014
    Terminated
    February 5, 2015
    Address
    14143 Denver West Pkwy, Lakewood, CO, 80401-3266

    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.

    Action

    Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.

    Distribution

    Worldwide Distribution.

    Quantity

    401,451