FDAFDA · Food and drugs·Recall number Z-1794-2012
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.
Published June 20, 2012 · Recall initiated: April 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Plasma Surgical Inc.
- Distributor
- Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
- Lot
- Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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