Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Reported: February 17, 2016 Initiated: November 10, 2015 #Z-0760-2016
Product Description
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
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.
Details
- Recalling Firm
- C.R. Bard, Inc.
- Units Affected
- 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.
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.. Recalled by C.R. Bard, Inc.. Units affected: 1,539.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2016. Severity: Moderate. Recall number: Z-0760-2016.
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