Events

Recall of Device Recall Richard Wolf Medical Instrument Corporation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard Wolf Medical Instruments Corp..

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
    68777
  • Event Risk Class
    Class 2
  • Event Number
    Z-0037-2015
  • Event Initiated Date
    2014-07-09
  • Event Date Posted
    2014-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128639
  • 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
    Richard wolf medical instrument corporation is recalling hulka clip tubal occluding device lot 51000232. the devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.
  • Action
    "Urgent: Medical Device Recall" letters dated July 9, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) inspect their inventories for the recalled products; 2) contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380 to notify Richard Wolf Medical Instruments if you have any devices in inventory; 3) review your records and report the number, if any, of Hulka Clips from lot 51000232 that were implanted in your patients on the Recall Response Form; 4) complete and return the Recall Response Form attached to the letter; and, 5) a RMA number will be provided to customers returning the recalled products and those customers will receive a credit. All returned product should be sent to the attention of Ms. Lisa Williams, Regulatory Specialist. Customers with questions can contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380.

Device

Device Recall Richard Wolf Medical Instrument Corporation
  • Model / Serial
    Product Code: 4986.09;  Lot: 51000232
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US (Nationwide) including states of: (AK, AL, CO, CT, FL, GA, IA, IN, KY, LA, MI, MO, MS, NC, NY, OH, OR, PA, SC, TN, TX, VA, WA, WV; and country of: Germany.
  • Product Description
    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • Manufacturer Address
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • Manufacturer Parent Company (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA