Events

Recall of Device Recall Arctic Sun ArcticGel Pads

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
    77469
  • Event Risk Class
    Class 3
  • Event Number
    Z-0590-2018
  • Event Initiated Date
    2017-06-02
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156096
  • 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
    Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number ndar0462.
  • Action
    Customers were notified on approximately 06/02/2017 via FedEx with delivery confirmation and per the individual country's delivery system. Instructions included to examine inventory and identify any product subject to the recall and notify customers if product was further distributed. If customers wished to return product, they were instructed to contact customer service at 1-800-526-4455.

Device

Device Recall Arctic Sun ArcticGel Pads
  • Model / Serial
    Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed domestically. Distributed internationally to Australia and Belgium.
  • Product Description
    Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
  • 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