CLASS II Device recall · Reported 20 Jun 2012 · FDA Enforcement Report
PlasmaJet Open Surgery Handpiece recalled by Plasma Surgical
Plasma Surgical is recalling PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System), distributed nationwide in the US. The recall was initiated on 27 Apr 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1794-2012
- FDA event ID
- 61951
- Recalling firm
- Plasma Surgical, Roswell, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2012
- FDA classified
- 11 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 27 Apr 2012 | Recall initiated by company | |
| 11 Jun 2012 | Classified by FDA | +45 days |
| 20 Jun 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Questions about this recall
Is PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) recalled?
Yes. Plasma Surgical recalled PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) on 27 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-1794-2012.
Why was it 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.
Which lots are affected?
Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
Where was it sold?
Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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