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Steris Corporation recalls AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthc
Recalled March 13, 2013 · FDA recall Z-0915-2013 · Steris
Hazard
The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance. · FDA Class II
Units
395 Units
Sold at
Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.
Description
The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.
Product
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Manufacturer(s)
Steris Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →