Drug recall
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is…
FDA recall event 61951 · Class II · Plasma Surgical Inc.
Key facts
| Event ID | 61951 |
|---|---|
| Recall numbers | Z-1794-2012 |
| Recalling firm | Plasma Surgical Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 27, 2012 |
| Report date | Jun 20, 2012 |
| Termination date | Nov 1, 2012 |
| City | Roswell |
| State | GA |
| Country | United States |
| FEI number | 3004754983 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: