Z-3042-2017 Class II Ongoing
FDA device recall Z-3042-2017 was initiated by C.R. Bard, Inc. on March 31, 2017 and is designated Class II. 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. The recall status is ongoing (terminated August 28, 2017). Affected quantity: 3,450 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 23, 2017
- Initiation Date
- March 31, 2017
- Termination Date
- August 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,450 units
Product Description
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
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.
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
Code Information
Product Codes 5000-00-00 & 5000-00-00E - All serial numbers