Company: Steris Corporation
Date of Enforcement Report: 5/6/2015
Class lI:
PRODUCT
AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Recall Number Z-1561-2015
REASON
STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.
RECALLING FIRM/MANUFACTURER
Steris Corporation, Mentor, OH on 2/19/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
701 units
DISTRIBUTION
Nationwide and Internationally
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