BEUDAMED
    FDA Recall Terminated

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    Recall: Z-1365-2015 · Initiated March 23, 2015

    Recall

    Recall Number
    Z-1365-2015
    Event Number
    70846
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    FEI Number
    2182208
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    March 23, 2015
    Posted
    April 2, 2015
    Terminated
    August 11, 2016
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391

    Description

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    Reason

    Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.

    Action

    Consignees were sent on 3/23/2015 a Medtronic "Urgent Medical Device Recall" letter dated March, 2015. The letter described the problem and the product involved in the recall. Consignees were advised to quarantine and return the product and to complete and return the Customer Confirmation Certificate to Medtronic. For questions contact your Medtronic Sales Representative or Customer Service a 1-800-716-6700.

    Distribution

    Worldwide Distribution: US (nationwide) including all states in continental USA, except DE and including DC and PR; and countries: AUSTRIA, AUSTRALIA, NEW ZEALAND, BELGIUM, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, IRELAND, ITALY, NETHERLANDS, POLAND, PORTUGAL, ROMANIA, RUSSIA, SPAIN, SWEDEN SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, EL SALVADOR, PANAMA, and CANADA.

    Quantity

    8,269 ( 6,786 US, 1,483 OUS)