Drug recall
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile…
FDA recall event 75055 · Class II · Ultroid Technologies, Inc.
Key facts
| Event ID | 75055 |
|---|---|
| Recall numbers | Z-0782-2017, Z-0783-2017, Z-0784-2017, Z-0785-2017 |
| Recalling firm | Ultroid Technologies, Inc. |
| Product type | Devices |
| Products | Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes, Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes, Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes., Ultroid Sterile Disposable Probes sold individually |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or… |
| Initiation date | Oct 19, 2016 |
| Report date | Dec 28, 2016 |
| Termination date | Dec 11, 2019 |
| City | Tampa |
| State | FL |
| Country | United States |
| FEI number | 3004892080 |
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: