C.R. Bard, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3042-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 31, 2017

Date Posted: August 23, 2017

Recall Number: Z-3042-2017

Event ID: 77794

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.

Status: Ongoing

Product Quantity: 3,450 units

Code Information:

Product Codes 5000-00-00 & 5000-00-00E - All serial numbers

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

Voluntary or Mandated:

Voluntary: Firm initiated