Recall Z-1617-2016 ยท DWJ System, Thermal Regulating
C.R. Bard, Inc.
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
| Date | May 6, 2016 (initiated Nov 9, 2015) |
| Status | Terminated |
| Reason | The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup. |
| Root cause | Unknown/Undetermined by firm |
| Action | BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation. Customers with questions were instructed to call 1-770-784-6471 or email bmd@crbard.com. For questions regarding this recall call 770-784-6220. |
| Quantity | 2613 |
| Distribution | Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Cana |
| 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 |