Recall Z-1561-2015— Steris Corporation

Name: FDA recall Z-1561-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-19

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2015-02-19, terminated 2016-01-20. It names 2 FDA 510(k) clearances: K112055, K111223. Product: 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.. Reason: 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..

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-02-19
Terminated: 2016-01-20
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K112055 — AMSCO CHIMERON MEDIUM STEAM STERILIZERSTERIS Corporation·cleared 2011-12-16
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, 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.

Reason for recall

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.

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