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Recall Observatory FDA recall evidence

Device product

Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

Z-0760-2016

November 10, 2015

Class II

Product summary

Firm
C.R. Bard, Inc.
Event
Event 72756
Status
Terminated
Classification
Class II
Quantity
1,539
Official record key
device-enforcement:Z-0760-2016

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.