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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 64440
Product Type Devices
Status Ongoing
Recalling Firm Steris Corporation
City Mentor
State OH
Country US
Voluntary/Mandated
Recall Initiation Date 2013-02-12
Initial Firm Notification of
Consignee or Public
Visit
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. AMSCO C: Serial Numbers: 021911201  023461202 AMSCO 400: Serial Numbers: 030181215-030291310 Class II 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. 395 Units Z-0915-2013
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