Recall Z-3042-2017 ยท DWJ System, Thermal Regulating
C.R. Bard, Inc.
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
| Date | Aug 16, 2017 (initiated Mar 31, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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, Ko |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 Medivance, Inc., Jul 16, 2010 |