C.R. Bard, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0760-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 10, 2015

Date Posted: February 17, 2016

Recall Number: Z-0760-2016

Event ID: 72756

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.

Status: Terminated

Product Quantity: 1,539

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.

Voluntary or Mandated:

Voluntary: Firm initiated