BEUDAMED
    FDA Recall Terminated

    Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.

    Recall: Z-1683-2012 · Initiated May 4, 2012

    Recall

    Recall Number
    Z-1683-2012
    Event Number
    57371
    Firm
    CaridianBCT, Inc.
    FEI Number
    1000117351
    Product Code
    LKN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 4, 2012
    Posted
    May 30, 2012
    Terminated
    November 27, 2012
    Address
    10811 W Collins Ave, Lakewood, CO, 80215-4440

    Description

    Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.

    Reason

    Defective product may result in decreased efficacy.

    Action

    Terumo BCT sent a Voluntary Medcal Device Safety Alert letter dated May 18, 2012 to each of their consignees via certified letter. The letter identified the affected product, problem, actions to be taken and instructions for healthcare providers until a corrective action is identified and implemented. Customers were instructed to share this safety alert with all those who need to be aware and complete the attached Acknowledgement Form and fax to +1.303.876.9277 or email to Terumo BCT. For questions contact your Terumo BCT Representative, the Terumo BCT Support Center at (U.S. Toll Free +1.877.339.4228) or +1.303.231.4357, or your local Terum BCT Customer Service Office.

    Distribution

    US Nationwide Distribution and the country of Canada.

    Quantity

    372 units