—#156096

Product

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

FDA product code: DWJ — System, Thermal Regulating
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K142702
Affected lot / code info: Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Distributed domestically. Distributed internationally to Australia and Belgium.

Timeline

Recall initiated: 2017-06-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.