Reported Dec 30, 2015 · Terminated

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

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DePuy Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Drive · Raynham, MA · 02767-5199

Is this the product you have?

  • VAPR¿ TRIPOLAR 90" Degree
  • Suction Electrodes (Model/Catalog No225028)
Lot codes and dates
  • U1509202 and U1509162
Amount recalled
127

Where it was sold

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 12, 2017 · Data as of Sep 19, 6:03 PM UTC

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