Drug recall
Plasmatherm V, Model/Catalog No. 00003296, Software plUS-201 V4
FDA recall event 94941 · Class II · Barkey Corporation
Key facts
| Event ID | 94941 |
|---|---|
| Recall numbers | B-0495-2024 |
| Recalling firm | Barkey Corporation |
| Product type | Biologics |
| Products | Plasmatherm V, Model/Catalog No. 00003296, Software plUS-201 V4 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Barkey GmbH & Co. KG (Barkey) is voluntarily recalling all plasmatherm V devices distributed in the United States due to the Food and Drug Administration s (FDA s) position that a new 510(k) clearance… |
| Initiation date | May 29, 2024 |
| Report date | Sep 25, 2024 |
| Termination date | Apr 17, 2025 |
| City | Woburn |
| State | MA |
| Country | United States |
| FEI number | 3019114108 |
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: