device · product 1 of 1
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
- Recall number
- Z-0760-2016
- Initiated
- November 10, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- C.R. Bard, Inc.
- Quantity
- 1,539
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Use error
Inspect official wording and provenance
Reason for recall
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.
Code information
All lots/serial numbers sold prior to August 2014.
Distribution pattern
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.