—#157892

Product

Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US

FDA product code: DWJ — System, Thermal Regulating
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K101092
Affected lot / code info: Product Codes 5000-00-00 & 5000-00-00E - All serial numbers

Why it was recalled

Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Bard sent an Urgent Customer Notification letter dated March 31, 2017, to each of the U.S. consignees. The letter contained recommended actions and included an Acknowledgement Form to be returned. For further questions, please call (770) 784-6119.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of : Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA

Timeline

Recall initiated: 2017-03-31
Posted by FDA: 2017-08-16
Terminated: 2017-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.