Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
This recall has been terminated (originally issued May 6, 2016).
- Company
- C.R. Bard, Inc.
- Recall Initiated
- November 9, 2015
- Posted
- May 6, 2016
- Terminated
- June 6, 2017
- Recall Number
- Z-1617-2016
- Quantity
- 2613
- Firm Location
- Covington, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
Distribution
Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom
Lot / Code Info
Product Codes - 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05
Root Cause
Unknown/Undetermined by firm
Action Taken
BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation. Customers with questions were instructed to call 1-770-784-6471 or email bmd@crbard.com. For questions regarding this recall call 770-784-6220.