FDA-Device2015-11-25Class II
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Sold states
Nationwide Distribution.
Affected count
992 units
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0296-2016Don't want to check this manually?
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