Recall Z-1595-2023— Steris Corporation

Name: FDA recall Z-1595-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-10

Class II · Ongoing

Class II FDA medical device recall by Steris Corporation, initiated 2023-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062. Reason: In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire..

Recalling firm: Steris Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-04-10
Firm location: Mentor, OH, United States

Product description

Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

Reason for recall

In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

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