Recall of Device Recall BARD(R) CRITICORE(R) MONITOR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. Bard, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Urinometer, electrical - Product Code EXS
  • Reason
    Bmd has identified that some lots of criticore(r) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
  • Action
    Bard Medical sent an Urgent Medical Device Product Recall letter dated November 10, 2017. Action required: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore Monitor Affected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or further distribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to this letter regardless of whether you have any of the affected product. Additional instructions for product return are contained on the form. "If you have further distributed any units with the referenced serial numbers, please identify your customers and notify them at once of this product recall: Your notification should include a copy of this letter and the accompanying enclosures. This recall should be carried out to the user level." For further questions, please call (770) 784-6120


  • Model / Serial
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Distribution and Internationally to Japan
  • Product Description
    BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series || The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
  • Manufacturer


  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
  • Source