PlasmaJet Open Surgery Handpiece recall
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is…
Why was PlasmaJet Open Surgery Handpiece 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
- Product
- PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is…
- Recalling firm
- Plasma Surgical Inc.
- Quantity
- 36 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
- Recall date
- June 20, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)