Mar

2013

Cl ll AMSCO Steam Sterilizers

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll AMSCO Steam Sterilizers

Amy Sellers

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