BEUDAMED
    FDA Recall Terminated

    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

    Recall: Z-0484-2015 · Initiated October 27, 2014

    Recall

    Recall Number
    Z-0484-2015
    Event Number
    69636
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HGI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 27, 2014
    Posted
    December 2, 2014
    Terminated
    May 29, 2015
    Address
    75 Vista Pl, Trumbull, CT, 06611-3934

    Description

    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

    Reason

    Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode

    Action

    CooperSurgical issued recall letter dated October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form. Customers with questions were instructed to call 203-601-5200.

    Distribution

    Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.

    Quantity

    595 units