Events

Recall of Device Recall Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit

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
    61945
  • Event Risk Class
    Class 2
  • Event Number
    Z-1806-2012
  • Event Initiated Date
    2012-05-11
  • Event Date Posted
    2012-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109561
  • 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
    Heparin, vascular access flush - Product Code NZW
  • Reason
    Manufacturer issued a voluntary recall on multiple lots of vy(tm)flush heparin lock flush syringes therefore vygon has subsequently initiated a recall on vygon branded heparin lock flush syringes and kits containing the syringes.
  • Action
    VYCON sent an URGENT MEDICAL DEVICE RECALL letter dated May 10, 2012, to all affected customers. The firm expanded their recall on May 25, 2012 by sending a second letter with additional lots and products. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected product. Customers should contact Vycon's Customer Service Department at 1-800-473-5414 for a Return Merchandise Authorization number. Customers were instructed to enter the number on the space provided on the Recall Acknowledgment and Inventory Return Form, sign and date form and fax to Vycon at 215-672-6740. Customers should return the affected product as well as the original signed Recall Acknowledgment and Inventory Form using the instructions from Customer Service involving product pick-up. All inventory will be credited. If product was further distributed the Urgent Medical Device Recall letter should be provided to their customers. For questions regarding this recall call 215-672-6740.

Device

Device Recall Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit
  • Model / Serial
    Product Code AMS-9437CP -- lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  • Product Description
    Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation