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U.S. Department of Health and Human Services

Class 3 Device Recall Arctic Sun ArcticGel Pads

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  Class 3 Device Recall Arctic Sun ArcticGel Pads see related information
Date Initiated by Firm June 02, 2017
Create Date February 12, 2018
Recall Status1 Open3, Classified
Recall Number Z-0590-2018
Recall Event ID 77469
510(K)Number K142702  
Product Classification System, thermal regulating - Product Code DWJ
Product Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Code Information Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.
Recalling Firm/
C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Labeling mix-ups
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.
Quantity in Commerce 128 units
Distribution Distributed domestically. Distributed internationally to Australia and Belgium.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.