Steris Corporation recalls AMSCO 5000 Series Washer/Disinfector Model # 5052

Recall date

December 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0996-2019

FDA classification

Class II

Brand / firm

Steris Corporation

Sold / distributed

The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and…

Why it was recalled

The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AMSCO 5000 Series Washer/Disinfector Model # 5052