Drug recall
Stay Safe Cap
FDA recall event 93396 · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 93396 |
|---|---|
| Recall numbers | Z-0507-2024 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | Stay Safe Cap |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Updating the labeling to include additional warnings and contraindications for potential side effects. |
| Initiation date | Oct 10, 2023 |
| Report date | Dec 13, 2023 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
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: