FDA-Device2013-05-08Class II
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Advanced Sterilization Products
Hazard
Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.
Sold states
Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN.
Affected count
69,994 cases
Manufactured in
33 Technology Dr, Irvine, CA, United States
Products
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1180-2013Don't want to check this manually?
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