Recall Z-0760-2016 ยท DWJ System, Thermal Regulating
C.R. Bard, Inc.
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
| Date | Feb 5, 2016 (initiated Nov 10, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |