FDA-Device2015-12-30Class II
VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard
Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
Sold states
Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.
Affected count
127
Manufactured in
325 Paramount Drive, N/A, Raynham, MA, United States
Products
VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2016Don't want to check this manually?
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