FDA-Device2014-12-03Class II
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
Market-Tiers Inc
Hazard
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
Sold states
Nationwide Distribution.
Affected count
100 units
Manufactured in
8097 Flint St, N/A, Lenexa, KS, United States
Products
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2145-2014Don't want to check this manually?
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