Events

Recall of Device Recall Vygon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Churchill Medical Systems, 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
    70369
  • Event Risk Class
    Class 2
  • Event Number
    Z-1467-2015
  • Event Initiated Date
    2015-01-15
  • Event Date Posted
    2015-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133341
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Potential for leaking caused by insufficient bond between needleless device and female luer.
  • Action
    Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them. If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return. Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.

Device

Device Recall Vygon
  • Model / Serial
    1304035, 1407046, 1410111D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
  • Product Description
    6" Trifurcated Extension Set, Product Code: AMS-375-1 || Accessory device used to administer medical fluids
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.