FDA-Device2017-12-13Class III

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

C.R. Bard, Inc.
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.

Sold states
Distributed domestically. Distributed internationally to Australia and Belgium.
Affected count
128 units
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2018

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