FDA-Device2019-03-20Class II
AMSCO 5000 Series Washer/Disinfector Model # 5052
Steris Corporation
Hazard
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.
Sold states
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 Taiwan.
Affected count
68
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
AMSCO 5000 Series Washer/Disinfector Model # 5052
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0996-2019Don't want to check this manually?
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