BEUDAMED
    FDA Enforcement Class I Terminated

    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    Recall: Z-2064-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2064-2012
    Event ID
    61747
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    June 8, 2012
    Classification Date
    August 14, 2012
    Termination Date
    August 23, 2016
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    Reason

    Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high flow device, to a passive drainage tube. June 12, 2012, customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Warning Labels, which are pending distribution, are required on all Neptune devices. Further investigation found the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. FDA advises Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.

    Code Info

    Neptune 2 Rover Ultra (120 V) 0702-001-000 Neptune 2 Rover Ultra (230 V) 0702-002-000 associated IFU 0702-002-700

    Distribution

    Worldwide Distribution -- USA (nationwide) and country of: Canada. .

    Quantity

    10,394 domestic, 276 international