BEUDAMED
    FDA Enforcement Class III Terminated

    Roth Net Polyp Retrieval

    Recall: Z-1416-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1416-2017
    Event ID
    76153
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    US Endoscopy Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    December 13, 2016
    Classification Date
    March 8, 2017
    Termination Date
    June 13, 2017
    Address
    5976 Heisley Rd, N/A, Mentor, OH, 44060-1873, United States

    Description

    Roth Net Polyp Retrieval

    Reason

    The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.

    Code Info

    Model # 0071151; Lot #s: 1613898, Exp. Date October 5, 2019; Lot # 1616337, Exp. Date October 7, 2019; Lot # 1616733, Exp. Date October 7, 2019; Lot # 1616734, Exp. Date October 20, 2019 & Lot # 1616735, Exp. Date October 28, 2019.

    Distribution

    US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.

    Quantity

    2,131 units