Events

Recall of Device Recall Churchill Medical

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
    59466
  • Event Risk Class
    Class 2
  • Event Number
    Z-3049-2011
  • Event Initiated Date
    2011-07-15
  • Event Date Posted
    2011-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102841
  • 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
    kit, i.v. start - Product Code LRS
  • Reason
    Outer kit labeled expiration date longer than the expiration of the shortest expired product.
  • Action
    Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com

Device

Device Recall Churchill Medical
  • Model / Serial
    Lot Numbers: 609134, 610166, 611100, 612074, 701180, 703021, 704088 706150, 707106, 708503, 709052, 710051, 711074, 711176 801504, 802064, 803116, 805120, 810040, 810150, 812020 902044, 903117, 906039, 907156, 908040, 910558, 912038 1007141
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Churchill Medical Latex-Free IV Start Kit || Product Code: AMS-623ATLF || The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label || AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.