BEUDAMED
    FDA Recall Terminated

    Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032

    Recall: Z-2163-2010 · Initiated June 8, 2010

    Recall

    Recall Number
    Z-2163-2010
    Event Number
    56037
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1000149028
    Product Code
    DTR
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 8, 2010
    Posted
    August 2, 2010
    Terminated
    May 7, 2012
    Address
    28 Howe St, Ashland, MA, 01721-1305

    Description

    Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032

    Reason

    Vent port may be occluded and prevent delivery of fluid

    Action

    Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.

    Distribution

    Distribution USA and Canada

    Quantity

    112 packs