Reported Dec 13, 2017 · Ongoing

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

C.R. Bard, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497

Is this the product you have?

  • Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Lot codes and dates
    • Product code 317-07
    • Lot Number NGAR0462
    • Device Listing Number D234021
Amount recalled
128 units

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:47 PM UTC

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