Events

Recall of Device Recall Arctic Sun 5000 and Arctic Sun 2000

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
    72756
  • Event Risk Class
    Class 2
  • Event Number
    Z-0760-2016
  • Event Initiated Date
    2015-11-10
  • Event Date Posted
    2016-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142163
  • 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
    Improper targeted temperature therapy was delivered to patients because the temperature simulator key was connected to the patient temperature cable instead of the patient temperature probe.
  • Action
    Bard Medical Division sent a Safety Alert to each of the customers via FedEx with proof of delivery notice. All consignees have been instructed to carry the notification out to the user-level.

Device

Device Recall Arctic Sun 5000 and Arctic Sun 2000
  • Model / Serial
    All lots/serial numbers sold prior to August 2014.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Product Description
    Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
  • 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