BEUDAMED
    FDA Enforcement Class II Terminated

    Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes

    Recall: Z-0289-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0289-2017
    Event ID
    74590
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    US Endoscopy Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    May 18, 2016
    Classification Date
    October 19, 2016
    Termination Date
    May 10, 2017
    Address
    5976 Heisley Rd, N/A, Mentor, OH, 44060-1873, United States

    Description

    Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes

    Reason

    US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.

    Code Info

    Model #: 00711819; Lot 1520268

    Distribution

    US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.

    Quantity

    36 units