Recall Z-0915-2013— Steris Corporation

Name: FDA recall Z-0915-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-12

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2013-02-12, terminated 2013-12-05. It names 2 FDA 510(k) clearances: K112403, K111223. Product: AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.. 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: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-02-12
Terminated: 2013-12-05
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K112403 — AMSCO CHIMERON MEDIUM STEAM STERLILZERSTERIS Corporation·cleared 2012-05-08
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 C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

Reason for recall

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.

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