Z-3042-2017Class II

Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US

Name: Z-3042-2017 Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Creator: C.R. Bard, Inc.
Published: 2017-03-31
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-03-31 / Terminated

FDA source

C.R. Bard, Inc. began a recall of Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US on 2017-03-31. FDA classified it as Class II and gives the reason as "Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3042-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-31
Posted: 2017-08-16
Terminated: 2017-08-28
Recalling firm: C.R. Bard Inc
Product: Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Product code: DWJ System, Thermal Regulating
Reason for recall: Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
FDA root cause: Unknown/Undetermined by firm
Action: Bard sent an Urgent Customer Notification letter dated March 31, 2017, to each of the U.S. consignees. The letter contained recommended actions and included an Acknowledgement Form to be returned. For further questions, please call (770) 784-6119.
Quantity in commerce: 3,450 units
Distribution: Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of : Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA
Product codes and lots: Product Codes 5000-00-00 & 5000-00-00E - All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3042-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3042-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-08-23	2017-08-16

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)