BEUDAMED
    FDA Enforcement Class II 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 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0484-2015
    Event ID
    69636
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    October 27, 2014
    Classification Date
    November 27, 2014
    Termination Date
    May 29, 2015
    Address
    75 Vista Pl, N/A, Trumbull, CT, 06611-3934, United States

    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

    Code Info

    Lot 159621 Exp Date: 2017-05

    Distribution

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

    Quantity

    595 units