Z-1617-2016Class II

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating...

Name: Z-1617-2016 Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating...
Creator: C.R. Bard, Inc.
Published: 2015-11-09
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2015-11-09 / Terminated

FDA source

C.R. Bard, Inc. began a recall of Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling... on 2015-11-09. FDA classified it as Class II and gives the reason as "The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1617-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-09
Posted: 2016-05-06
Terminated: 2017-06-06
Recalling firm: C.R. Bard Inc
Product: Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Product code: DWJ System, Thermal Regulating
Reason for recall: The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
FDA root cause: Unknown/Undetermined by firm
Action: BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation. Customers with questions were instructed to call 1-770-784-6471 or email [email protected]. For questions regarding this recall call 770-784-6220.
Quantity in commerce: 2613
Distribution: Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom
Product codes and lots: Product Codes - 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1617-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1617-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-06

Product code DWJ

K101092Class IIArctic Sun Temperature Management System, Model 5000Medivance, Inc. / cleared 2010-07-16

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)