FDA-Device2018-03-07Class II
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Hazard
Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
Sold states
Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Republic of Korea, Kuwait, Latvia, Malaysia, Mexico, Morocco, Myanmar, Panama, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and Vietnam.
Affected count
406
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0772-2018More Steris Corporation recalls
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