BEUDAMED
    FDA Enforcement Class II Terminated

    Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.

    Recall: Z-2269-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2269-2014
    Event ID
    68768
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    July 8, 2014
    Classification Date
    August 19, 2014
    Termination Date
    May 7, 2015
    Address
    6655 Wedgwood Rd N Ste 160, Osseo, MN, 55311-3613, United States

    Description

    Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.

    Reason

    Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.

    Code Info

    catalog No.: 000878-4, not lot controlled.

    Distribution

    Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, ,MN, MS, NH, HY, OH,OR, PA, TN TX, UT, VA, WA, WI,and WV. and the country of CANADA.

    Quantity

    507 units