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U.S. Department of Health and Human Services

Class 2 Device Recall Arctic Sun 5000 and Arctic Sun 2000

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 Class 2 Device Recall Arctic Sun 5000 and Arctic Sun 2000see related information
Date Initiated by FirmNovember 10, 2015
Date PostedFebruary 05, 2016
Recall Status1 Terminated 3 on April 21, 2017
Recall NumberZ-0760-2016
Recall Event ID 72756
510(K)NumberK071341 K101092 
Product Classification System, thermal regulating - Product Code DWJ
ProductArctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Code Information All lots/serial numbers sold prior to August 2014.
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactSherry Saurini
770-784-6119
Manufacturer 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 Determined
Cause 2		Use error
ActionBard 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 Commerce1,539
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DWJ
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