Medical device recalls Moderate risk

Nussloch GmbH ASP6025 Tissue Processor recalled over labeling errors

Recall date
June 19, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Leica Microsystems, Inc. recalls Nussloch GmbH ASP6025 Tissue Processor
Recall number
Z-2660-2017
FDA classification
Class II
Brand / firm
Leica Microsystems, Inc.
Sold / distributed
Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia,…

Why it was recalled

Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.

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

What was recalled

Nussloch GmbH ASP6025 Tissue Processor

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