Recall of Device Recall Willscher Vas Reapproximator Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Surgical instruments, g-u, manual (and accessories) - Product Code KOA
  • Reason
    Cook medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
  • Action
    The firm, Cook Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 26, 2017 to its customers. Letters were mailed to customers via courier on April 28, 2017. The letter described the product, problem, and actions to be taken. The customers were instructed to: examine your inventory immediately to identify and quarantine affected products; complete and return the required Acknowledgment and Receipt form (even if you do not have affected product) via fax (812.339.7316) or email (; return and discard any affected products, and Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.


  • Model / Serial
    CATALOG NUMBER: 092000, GPN: G14500, Dates of Manufacture: January 2012 to March 2016.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.
  • Product Description
    Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. || Used to stabilize the vas ends during microscopic vasovasostomy.
  • Manufacturer


  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
  • Source