BEUDAMED
    FDA Enforcement Class II Terminated

    DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03

    Recall: Z-0195-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0195-2020
    Event ID
    83386
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Valeritas, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    July 3, 2019
    Classification Date
    October 26, 2019
    Termination Date
    June 24, 2020
    Address
    293 Boston Post Rd W Ste 330, Marlborough, MA, 01752-4615, United States

    Description

    DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03

    Reason

    There is a potential for "No Needle Demo Units" to contain a needle.

    Code Info

    UDI: (01)10385609020039(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM218001 DM218002 DM218003 DM218004 DM218005 DM218006 DM218020 DM218025 DM218034 DM218035 DM218036

    Distribution

    Nationwide within U.S.

    Quantity

    49,074 devices