Z-2536-2018Class II

Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal...

Name: Z-2536-2018 Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal...
Creator: Bard Medical Division
Published: 2018-06-13
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2018-06-13 / Terminated / root cause: manufacturing process

FDA source

Bard Medical Division began a recall of Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and... on 2018-06-13. FDA classified it as Class II and gives the reason as "An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system". 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-2536-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-13
Posted: 2018-07-24
Terminated: 2021-02-16
Recalling firm: C.R. Bard Inc
Product: Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32C to 38.5C (89.6F to 101.3F) in adult and pediatric patients of all ages.
Product code: DWJ System, Thermal Regulating
Reason for recall: An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm,Bard Medical, sent a "MEDICAL DEVICE CORRECTION" letter dated 6/13/2018 to its customers. Bard Medical advised their customers to examine inventory and identify any ARCTIC SUN 5000 Temperature Management Systems that match the attached Serial Number List they sent with the letter. The firm also asked their customers to complete the online acknowledgement form(link was provided in the letter) if a customer had an ARCTIC SUN 5000 Temperature Management Systems that matches the serial number list. If a customer had further distributed or transferred an ARCTIC SUN 5000 Temperature Management System, Bard Medical advised the customer to please identify the respective organizations and notify them at once of this communication, including a copy of this communication letter and accompanying attachments and to have the organization promptly complete the online acknowledgement form in the link provided. Upon completion of the online acknowledgement form, the customer will be contacted by a customer service representative to schedule the unit(s) for repair. The link to the Online Acknowledgement Form: www.novasyte.com/as5000 Bard Medical stated they partnered with Novasyte to assist in this action. Novasyte contact information is as follows: Phone: (760) 507-1908 Email: [email protected]
Quantity in commerce: 5608 Units Total
Distribution: Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide Distribution: Canada, Austria, Bahrain, Belgium, Brazil, Brussels China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Guam, Hungary, Iran, Italy, Jordan, Korea, Luxemburg, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Vietnam.
Product codes and lots: Model #5000 Product codes: 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05, 5000-00-06, 5000-01-07, 5000-01-08. All serial numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2536-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2536-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-24

Product code DWJ

K161602Class IIArctic Sun Temperature Management SystemMedivance, Inc. / cleared 2016-09-02

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)