Events

Recall of Churchill Medical Systems

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

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
    58794
  • Event Risk Class
    Class 1
  • Event Number
    Z-2389-2011
  • Event Initiated Date
    2011-04-19
  • Event Date Posted
    2011-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100308
  • 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
    Central Line Dressing Kit - Product Code LKB
  • Reason
    Skin-prep wipes purchased by churchill (a vygon company) for inclusion into dressing kits and picc insertion kits were recalled by the manufacturer due to potential bacterial contamination.
  • Action
    A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.

Device

Churchill Medical Systems
  • Model / Serial
    Lot Numbers: 10I60, 10K42 and 10F87.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    United States (FL, MA, MD, and VA).
  • Product Description
    Churchill Medical Systems || AMS-8316CP-1 (Central Line Dressing Kit). || The device intended use is a central line dressing kit.
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation