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 40041exp. date February 2015 and Lot Number 40043exp. 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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