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Class 2 Device Recall Arctic Sun 5000 and Arctic Sun 2000 |
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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
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Product Classification |
System, thermal regulating - Product Code DWJ
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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
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For Additional Information Contact |
Sherry Saurini 770-784-6119
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.
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