Events

Recall of Device Recall Arctic Sun 5000 Temperature Management System

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
    Recall
  • Event ID
    73827
  • Event Risk Class
    Class 2
  • Event Number
    Z-1617-2016
  • Event Initiated Date
    2015-11-09
  • Event Date Posted
    2016-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145059
  • 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
    System, thermal regulating - Product Code DWJ
  • Reason
    The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and static random access memory (sram). this premature coin cell battery drainage could render the device unresponsive upon system startup.
  • Action
    BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation. Customers with questions were instructed to call 1-770-784-6471 or email bmd@crbard.com. For questions regarding this recall call 770-784-6220.

Device

Device Recall Arctic Sun 5000 Temperature Management System
  • Model / Serial
    Product Codes - 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom
  • Product Description
    Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V || The product is a thermal regulating system indicated for monitoring and controlling patient temperature
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

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