Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
FDA Recall Z-3042-2017 · Posted 2017-08-16
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Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeDWJ
Date Initiated2017-03-31
Date Terminated2017-08-28
Product Quantity3,450 units
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.
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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