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Plasma Surgical Inc. recalls PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neut
Recalled June 20, 2012 · FDA recall Z-1794-2012 · Plasma Surgical
Hazard
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. · FDA Class II
Units
36 units
Sold at
Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Description
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.
Product
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.
Manufacturer(s)
Plasma Surgical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →