BEUDAMED
    FDA Recall 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 · Initiated May 18, 2016

    Recall

    Recall Number
    Z-0289-2017
    Event Number
    74590
    Firm
    US Endoscopy Group Inc
    FEI Number
    1000122656
    Product Code
    FBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 18, 2016
    Posted
    October 19, 2016
    Terminated
    May 10, 2017
    Address
    5976 Heisley Rd, Mentor, OH, 44060-1873

    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.

    Action

    US Endoscopy sent an Urgent- (Vari Safe) injection needle recall letter dated July 6, 2016. US Endoscopy requests that you: 1.Quarantine the affected Vari-Safe Injection devices in your stock. 2. Destroy each affected device by opening the device package, cutting the device catheter with a scissors, and then discarding the device and package. 3.Complete the attached Customer Response Card and return to the attention of US Endoscopy Customer Service, via fax 1-440-639-4495 or email orders@us endos copy.com . A no charge replacement will be provided for each unused Vari-Safe Injection Needle device from the affected lot. We apologize for any inconvenience this matter may cause you, and as always, US Endoscopy is dedicated to supporting our products and valued Customers. For further questions please call (800) 769-8226.

    Distribution

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

    Quantity

    36 units