Events

Recall of Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1

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
    64464
  • Event Risk Class
    Class 2
  • Event Number
    Z-0914-2013
  • Event Initiated Date
    2013-01-21
  • Event Date Posted
    2013-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116188
  • 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
    The label on the device states that the item number is clgy-2210 when the item number on the device label should read clgy-2010. this is a 20ga huber needle set; however, the product label states the pouch contains a 22ga set.
  • Action
    Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com. For questions regarding this recall call 603-743-5988.

Device

Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1
  • Model / Serial
    Lot #1210099
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
  • Product Description
    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 || Huber type needle set used for the infusion of medical fluids into implantable ports.
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.