Events

Recall of Device Recall FalopeRing Dilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gyrus Medical, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68768
  • Event Risk Class
    Class 2
  • Event Number
    Z-2269-2014
  • Event Initiated Date
    2014-07-08
  • Event Date Posted
    2014-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128626
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, occlusion, tubal, contraceptive - Product Code KNH
  • 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 laura.storms@olympus.com

Device

Device Recall FalopeRing Dilator
  • Model / Serial
    catalog No.: 000878-4, not lot controlled.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product 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.
  • Manufacturer
    Gyrus Medical, Inc

Manufacturer

Gyrus Medical, Inc
  • Manufacturer Address
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA