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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 2000 see related information
Date Initiated by Firm November 10, 2015
Date Posted February 05, 2016
Recall Status1 Terminated 3 on April 21, 2017
Recall Number Z-0760-2016
Recall Event ID 72756
510(K)Number K101092  K071341  
Product Classification System, thermal regulating - Product Code DWJ
Product Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Code Information All lots/serial numbers sold prior to August 2014.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Sherry 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.
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