BEUDAMED
    FDA Recall Terminated

    Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.

    Recall: Z-0078-2008 · Initiated September 18, 2007

    Recall

    Recall Number
    Z-0078-2008
    Event Number
    44915
    Firm
    Gambro BCT, Inc.
    FEI Number
    1000117351
    Product Code
    LKN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 18, 2007
    Posted
    October 31, 2007
    Terminated
    January 25, 2008
    Address
    10811 W Collins Ave, Lakewood, CO, 80215-4440

    Description

    Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.

    Reason

    Under specific conditions, apheresis machine could return up to 60mL of air to the patient.

    Action

    All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information.

    Distribution

    US, Canada, Australia, Europe.

    Quantity

    15 units