BEUDAMED
    FDA Recall Terminated

    Prisma continuous renal replacement system.

    Recall: Z-1545-05 · Initiated August 16, 2005

    Recall

    Recall Number
    Z-1545-05
    Event Number
    33120
    Firm
    Gambro Renal Products
    FEI Number
    1713683
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 16, 2005
    Posted
    October 1, 2005
    Terminated
    January 3, 2012
    Address
    10810 W Collins Ave, Lakewood, CO, 80215-4439

    Description

    Prisma continuous renal replacement system.

    Reason

    Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.

    Action

    Consignees were notified by press release and letter on 8/16/2005.

    Distribution

    Nationwide, including Puerto Rico and Washington, DC. Military consignees in CA and TX. VA consignees in AZ, CA, DC, FL, GA, MO, OH, OR, PA, PR, TX, UT, VA and WI. No foreign distribution by US firm.

    Quantity

    1964 units