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FDAFDA · Food and drugs·Recall number Z-3042-2017

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

Published August 23, 2017 · Recall initiated: March 31, 2017

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
C.R. Bard, Inc.
Distributor
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
Lot
Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
Risk classification
Class II
Area (FDA)
device
Country
United States

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