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FDAFebruary 19, 2015device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

steris

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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