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U.S. Department of Health and Human Services

Class 2 Device Recall Arctic Sun 5000 Temperature Management System

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  Class 2 Device Recall Arctic Sun 5000 Temperature Management System see related information
Date Initiated by Firm March 31, 2017
Date Posted August 16, 2017
Recall Status1 Terminated 3 on August 28, 2017
Recall Number Z-3042-2017
Recall Event ID 77794
510(K)Number K101092  
Product Classification System, thermal regulating - Product Code DWJ
Product Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Code Information Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Michael J.Crader
770-784-6119
Manufacturer Reason
for Recall		 Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Bard sent an Urgent Customer Notification letter dated March 31, 2017, to each of the U.S. consignees. The letter contained recommended actions and included an Acknowledgement Form to be returned. For further questions, please call (770) 784-6119.
Quantity in Commerce 3,450 units
Distribution Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of : Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.
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