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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