Events

Recall of Churchill Medical Systems

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
    54174
  • Event Risk Class
    Class 2
  • Event Number
    Z-1639-2010
  • Event Initiated Date
    2009-10-20
  • Event Date Posted
    2010-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87763
  • 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
    Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents.
  • Action
    Churchill Medical Systems issued an "Urgent: Product Advisory Customer Notification" dated October 20, 2009 requesting return of affected product and notification to end users. For further information, contact Churchill Medical Systems at 1-603-743-5988 or via fax at 1-603-743-6328.

Device

Churchill Medical Systems
  • Model / Serial
    Lot Numbers: 903005, 904057, 904060, 904061, 904062, 904063, 905089, 905090, 905091, 906199, 907005, 907006, 907007, 909014, 909015, 909016, 909017, 909018, 909026, 909031, 909032, 909033, 909034, 909035, 909036 and 909037.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to Florida.
  • Product Description
    Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. || Intravascular administration set.
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.