Device recall: Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

Class II FDA enforcement event 72756. Recall start date: 10 Nov 2015. Status in the FDA record: Terminated. Termination date: 21 Apr 2017.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

C.R. Bard, Inc. started this device recall on 10 Nov 2015. The firm address in the FDA record is in Covington, GA. FDA put the recall in Class II. FDA event 72756 has 1 product record. The first FDA enforcement report date is 17 Feb 2016. The record gives the status Terminated, with the termination date 21 Apr 2017.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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,…

Recalling firm

C.R. Bard, Inc., Covington, GA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 72756: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0760-2016	Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.	1,539	Class II	Terminated	17 Feb 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 49

Other events of the firm

Other FDA enforcement events of C.R. Bard, Inc.
Initiated	Product (first record)	Type	Class	Records
25 Jun 2026	Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 0080	Device	Class II	6
23 Apr 2026	Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Cath	Device	Class II	1
6 Nov 2025	Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614	Device	Class II	4
17 Jul 2025	SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A	Device	Class II	3
18 Jun 2025	Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF	Device	Class II	1
3 Jun 2025	BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF:	Device	Class II	3
17 Apr 2025	Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (2	Device	Class I	5
9 May 2024	Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection	Device	Class II	1
20 Dec 2023	Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100	Device	Class II	17
15 Nov 2023	Sensica Urine Output System, Catalog Number SCCS1002	Device	Class II	1

C.R. Bard, Inc.: all 49 events

Official channels

FDA enforcement report Z-0760-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 72756. https://recallregister.com/fda/ii/72756/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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,…
What quantity of product is in FDA event 72756?: The FDA record gives this quantity: 1,539
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.