Drug recall
Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product…
FDA recall event 83909 · Class II · Applied Medical Resources Corp
Key facts
| Event ID | 83909 |
|---|---|
| Recall numbers | Z-0509-2020, Z-0510-2020 |
| Recalling firm | Applied Medical Resources Corp |
| Product type | Devices |
| Products | Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy…, GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. |
| Initiation date | Dec 12, 2018 |
| Report date | Nov 27, 2019 |
| Termination date | Jan 22, 2021 |
| City | Rancho Santa Margarita |
| State | CA |
| Country | United States |
| FEI number | 2027111 |
At a glance
- 1–9 Products in this recall
- 10–99 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: