BEUDAMED
    FDA Recall Terminated

    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

    Recall: Z-1879-2018 · Initiated March 12, 2018

    Recall

    Recall Number
    Z-1879-2018
    Event Number
    79828
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HGI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 12, 2018
    Terminated
    May 8, 2019
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

    Reason

    Products have been packaged with an incorrect product size.

    Action

    On March 26, 2018 CooperSurgical mailed medical device recall notification letters to affected customers. Customers were instructed to: please discontinue use of any of the lots listed in the table above and complete the attached Acknowledgement and Receipt Form to schedule refund or exchange. If you have supplied or transferred any potentially affected product to another facility or organization, please let them know of the recall by providing a copy of this letter. If you have any further questions, please feel free to contact CooperSurgical at [email protected].

    Distribution

    CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain

    Quantity

    500