BEUDAMED
    FDA Recall Terminated

    Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .

    Recall: Z-0298-03 · Initiated November 7, 2002

    Recall

    Recall Number
    Z-0298-03
    Event Number
    25078
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1000149028
    Product Code
    DTR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2002
    Posted
    April 3, 2003
    Terminated
    August 6, 2015
    Address
    28 Howe St, Ashland, MA, 01721-1305

    Description

    Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .

    Reason

    Heat exchanger may contain loose particulate matter

    Action

    Terumo Cardiovascular Systems notified customers by telephone on 11/8/02 by telephone, fax, and mail to advise distributors and end-users to cease use of the Heat Coil.. A follow-up letter issued to the accounts with instructions for the return of product.

    Distribution

    Nationwide. AR, CA, OH, FL, GA, IN, LA, MN, NJ, PA, TN, TX, WA, WI

    Quantity

    10035