Recall Z-0210-2016— Steris Corporation

Name: FDA recall Z-0210-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Class III · Terminated

Class III FDA medical device recall by Steris Corporation, initiated 2015-09-03, terminated 2016-01-22. It names one FDA 510(k) clearance: K111223. Product: AMSCO 400 and AMSCO C Small Steam Sterilizers. 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: Steris Corporation
Classification: Class III
Status: Terminated
Initiated: 2015-09-03
Terminated: 2016-01-22
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K111223 — AMSCO CHIMERON SMALL STEAM STERILIZERSTERIS Corporation·cleared 2011-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AMSCO 400 and AMSCO C Small Steam Sterilizers

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.