DePuy Mitek, Inc., a Johnson & Johnson Co. recalls VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)

Recall date

November 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0479-2016

FDA classification

Class II

Brand / firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Sold / distributed

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.

Why it was recalled

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

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

What was recalled

VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)