Company:Steris Corporation
Date of Enforcement Report 3/13/2013
Class ll:
PRODUCT
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Recall Number Z-0915-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Steris Corporatio., Mentor, OH on 2/12/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
395 Units
DISTRIBUTION
Worldwide
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