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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
AMSCO C and AMSCO 400 Steam Sterilizers		see related information
Date Posted March 06, 2013
Recall Number Z-0915-2013
Product AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Code Information AMSCO C: Serial Numbers: 021911201  023461202 AMSCO 400: Serial Numbers: 030181215-030291310
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
Reason for
Recall		 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.
Action Steris Corporation initiated their recall on February 12, 2013. They will notify customers via onsite visits by STERIS Field Service Technicians to each affected Customer site. For further questions, please call (440) 392-7601.
Quantity in Commerce 395 Units
Distribution 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.
 
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