Z-1395-2016Class II

BARD ArcticGel Pads

Name: Z-1395-2016 BARD ArcticGel Pads
Creator: C.R. Bard, Inc.
Published: 2016-03-04
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-03-04 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc. began a recall of BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads... on 2016-03-04. FDA classified it as Class II and gives the reason as "Complaints were received of restricted/inaccurate flow rate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1395-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-04
Posted: 2016-04-14
Terminated: 2017-12-07
Recalling firm: C.R. Bard Inc
Product: BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
Product code: DWJ System, Thermal Regulating
Reason for recall: Complaints were received of restricted/inaccurate flow rate.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Bard Medical sent an Urgent Medical Product Recall letter dated March 4, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to not use any of the affected products and to return any unused product Bard Medical Division via the provided Customer Recall and Effectiveness Form. BMD will be providing a replacement for the returned product. If the product was further distributed, the consignee was instructed to identify their customers and notify them of the product recall.
Quantity in commerce: 21,412 units
Distribution: Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay and Vietnam.
Product codes and lots: All lots with Catalog numbers: 31700 (Universal Pad), 3170004 (Universal Pad 4 pk), 31703 (XSmall pad kit), 3170302 (XSmall pad kit 2 pk), 31705 (Small pad kit), 3170502 (Small pad kit 2 pk), 31707 (Medium pad kit), 3170702 (Medium pad kit 2 pk), 31709 (Large pad kit) and 3170902 (Large pad kit 2 pk), that are within their current expiration dates.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1395-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

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)