Nov

2015

Cl II AMSCO Small Steam Sterilizers

Company: Steris Corporation
Date of Enforcement Report 11/11/2015
Class lI:

PRODUCT

AMSCO 400 and AMSCO C Small Steam Sterilizers
Recall Number Z-0210-2016

REASON
In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door..

RECALLING FIRM/MANUFACTURER
Steris Corporation, Mentor, OH on 9/3/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
32 units

DISTRIBUTION
Nationwide

___________________________________

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 II AMSCO Small Steam Sterilizers

Amy Sellers

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