Z-0760-2016Class II

Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures

Name: Z-0760-2016 Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures
Creator: C.R. Bard, Inc.
Published: 2015-11-10
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2015-11-10 / Terminated

FDA source

C.R. Bard, Inc. began a recall of Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures on 2015-11-10. FDA classified it as Class II and gives the reason as "Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0760-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Posted: 2016-02-05
Terminated: 2017-04-21
Recalling firm: C.R. Bard Inc
Product: Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Product code: DWJ System, Thermal Regulating
Reason for recall: Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
FDA root cause: Use error
Action: Bard Medical Division sent a Safety Alert to each of the customers via FedEx with proof of delivery notice. All consignees have been instructed to carry the notification out to the user-level.
Quantity in commerce: 1,539
Distribution: Nationwide Distribution-DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
Product codes and lots: All lots/serial numbers sold prior to August 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0760-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0760-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-05

Product code DWJ

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)