Z-0590-2018Class III

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

Name: Z-0590-2018 Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Creator: C.R. Bard, Inc.
Published: 2017-06-02
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-06-02 / Open, Classified / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 on 2017-06-02. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0590-2018
Classification: Class III
Status: Open, Classified
Initiated: 2017-06-02
Posted: 2018-02-12
Recalling firm: C.R. Bard Inc
Product: Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Product code: DWJ System, Thermal Regulating
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0590-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0590-2018	Class III	Ongoing	Voluntary: Firm initiated	2017-12-13	2018-02-12

Product code DWJ

K142702Class IIArctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadMedivance, Inc. / cleared 2014-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)