FDA Device

Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

Hazard

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.

What You Should Do

Remedy

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.

Products

Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Brand
C.R. Bard, Inc.
UPC
Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.

Units Affected

128 units