Drug recall
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
FDA recall event 90837 · Class II · Steris Corporation
Key facts
| Event ID | 90837 |
|---|---|
| Recall numbers | Z-0079-2023 |
| Recalling firm | Steris Corporation |
| Product type | Devices |
| Products | Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also… |
| Initiation date | Sep 2, 2022 |
| Report date | Oct 19, 2022 |
| Termination date | Jan 2, 2025 |
| City | Mentor |
| State | OH |
| Country | United States |
| FEI number | 1527821 |
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: