Recall Z-0760-2016
C.R. Bard, Inc. · initiated November 10, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Codes / lots: All lots/serial numbers sold prior to August 2014.
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.
FDA-determined cause: Use error
Action taken
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.
Details
- Recall number
- Z-0760-2016
- Initiated
- November 10, 2015
- Posted by FDA
- February 5, 2016
- Terminated
- April 21, 2017
- Product code
- DWJ – System, Thermal Regulating
- 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.
- Recalling firm
- C.R. Bard, Inc., Covington, GA