BEUDAMED
    FDA Recall 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 · Initiated July 8, 2014

    Recall

    Recall Number
    Z-2269-2014
    Event Number
    68768
    Firm
    Gyrus Medical, Inc
    FEI Number
    3011050570
    Product Code
    KNH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 8, 2014
    Posted
    August 19, 2014
    Terminated
    May 7, 2015
    Address
    6655 Wedgwood Rd N, Ste 160, Osseo, MN, 55311-3613

    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.

    Action

    Olympus sent a "Medical Device Recall" letter dated July 7, 2014 to affected customers. The letter was addressed to Surgery Department & Risk Management Department. The letter described the product being recalled, problem and actions to be take. Consignees were advised to immediately cease further use of any affected product and to remove and discard it. Customers were to fax the completed questionnaire to 484-896-7128. For questions contact Laura Storms at 484-896-5688 or at [email protected]

    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