BEUDAMED
    FDA Recall Terminated

    Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.

    Recall: Z-1541-2012 · Initiated June 1, 2010

    Recall

    Recall Number
    Z-1541-2012
    Event Number
    53196
    Firm
    CaridianBCT, Inc.
    FEI Number
    1000117351
    Product Code
    KZE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 1, 2010
    Posted
    May 11, 2012
    Terminated
    July 25, 2012
    Address
    10811 W Collins Ave, Lakewood, CO, 80215-4440

    Description

    Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.

    Reason

    Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets.

    Action

    CaridianBCT sent a Letter notification dated March 2011 to consignees The letter identified the upcoming software updates to version 6.0.1 as well as operations manual changes. For questions contact your CaridianBCT Representative, the CaridianBCT Support Center at +1-877-339-4228 or 1-303-231-4357 or your local CaridianBCT Customer Service office.

    Distribution

    USA Nationwide Distribution

    Quantity

    2278 units