BEUDAMED
    FDA Recall Terminated

    Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catalog No. 804113)

    Recall: Z-1311-2008 · Initiated January 29, 2008

    Recall

    Recall Number
    Z-1311-2008
    Event Number
    46869
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    OEZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 29, 2008
    Posted
    March 28, 2008
    Terminated
    July 7, 2009
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catalog No. 804113)

    Reason

    Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.

    Action

    Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.

    Distribution

    Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.

    Quantity

    110