BEUDAMED
    FDA Recall Terminated

    Roth Net Polyp Retrieval

    Recall: Z-1416-2017 · Initiated December 13, 2016

    Recall

    Recall Number
    Z-1416-2017
    Event Number
    76153
    Firm
    US Endoscopy Group Inc
    FEI Number
    1000122656
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    December 13, 2016
    Posted
    March 8, 2017
    Terminated
    June 13, 2017
    Address
    5976 Heisley Rd, Mentor, OH, 44060-1873

    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.

    Action

    US Endoscopy Group sent an Urgent: Roth Net Polyp Retriever Recall letter dated January 6, 2017, to all affected customers. The firm requested their customers to do the following: 1. Quarantine and destroy the affected Roth Net devices in your inventory. 2. Contact US Endoscopy Customer Service at 1-800-769-8226 to obtain no cost replacement product. 3. Complete and return the attached Response Card. For further information please call (440) 358-6055.

    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