Recall Z-3042-2017
C.R. Bard, Inc. · initiated March 31, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Codes / lots: Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
Reason for recall
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-3042-2017
- Initiated
- March 31, 2017
- Posted by FDA
- August 16, 2017
- Terminated
- August 28, 2017
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 3,450 units
- Distribution
- 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
- Recalling firm
- C.R. Bard, Inc., Covington, GA