Events

Recall of Device Recall AMS636, 60" Microbore extension set.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vygon MFG, Inc., dba/ 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
    76607
  • Event Risk Class
    Class 2
  • Event Number
    Z-1484-2017
  • Event Initiated Date
    2017-02-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153644
  • 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
    Incorrect priming volume printed on the device package.
  • Action
    Recall letters were sent to the customer via email and fax on 2/20/2017. They were asked to take the following actions: The recall will be conducted at no cost to you. To effect return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2. Count and document your affected inventory on the "Recall Acknowledgement and Inventory Return Form; 3. Fax or email the form to Vygon including customer contact information; 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up; 6. All inventory will be credited or replaced at no cost to you. If you have questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-4 73-5414, or by e-mail at customerservice@vygonus.com.

Device

Device Recall AMS636, 60" Microbore extension set.

Manufacturer

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
  • Manufacturer Address
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., 87 Venture Dr, Dover NH 03820-5914
  • Manufacturer Parent Company (2017)
    Soc Part Financiere Pierre Simonet
  • Source
    USFDA