Medical device recalls Moderate risk

Steris Corporation recalls V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)

Recall date
September 28, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0772-2018
FDA classification
Class II
Brand / firm
Steris Corporation
Sold / distributed
Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei…

Why it was recalled

Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.

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

What was recalled

V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)

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