Reported Jun 20, 2012 · Terminated

PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a…

Plasma Surgical Inc.

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: Plasma Surgical Inc. · 1009 Mansell Rd Ste F · Roswell, GA · 30076-4806

Is this the product you have?

  • PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.
Lot codes and dates
    • Lot Number 40041
    • exp. date February 2015 and Lot Number 40043
    • exp. date February 2015
Amount recalled
36 units

Where it was sold

Why it was recalled

Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.

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 Nov 1, 2012 · Data as of Sep 19, 6:13 PM UTC

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