Plasma Surgical Recalls PlasmaJet Open Surgery Handpieces Due to Seal Failure
Plasma Surgical Inc. is recalling 36 PlasmaJet Open Surgery Handpieces because a potential seal failure may cause a small drop of distilled water coolant to leak during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to a small leak of distilled water coolant with no reported injuries or illnesses, fitting the criteria for a moderate risk or voluntary precautionary recall.
Plain-English summary
Plasma Surgical Inc. is recalling 36 units of the PlasmaJet Open Surgery Handpiece, which is part of the PlasmaJet Neutral Plasma Surgery System. This system is designed for cutting and coagulation in open and laparoscopic surgery. The affected units are identified by Lot Number 40041 and Lot Number 40043, both with an expiration date of February 2015.
The recall is being conducted due to a potential failure in the glued seal between the stem and the tip of the handpiece. This defect could lead to the leakage of a very small drop of distilled water coolant from the handpiece while it is in use.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting California and New York) and in the United Kingdom. Healthcare facilities and users should stop using the affected handpieces and contact Plasma Surgical Inc. for further instructions.
The recalled product
- 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
- Plasma Surgical Inc.
- Hazard
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Number 40041
- exp. date February 2015 and Lot Number 40043
- exp. date February 2015
Distribution
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