Events

Recall of Device Recall CVC Tray Pediatrics

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
    78951
  • Event Risk Class
    Class 2
  • Event Number
    Z-0680-2018
  • Event Initiated Date
    2017-07-24
  • 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=160956
  • 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
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Reason
    Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our tyvek supplier has notified vygon of issues with their product, specifically the tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. this potential lack of adhesive may affect the sterility of the product.
  • Action
    Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.

Device

Device Recall CVC Tray Pediatrics

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