Drug recall
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA recall event 87814 · Class II · Quanta System, S.p.A.
Key facts
| Event ID | 87814 |
|---|---|
| Recall numbers | Z-1842-2021, Z-1843-2021, Z-1844-2021 |
| Recalling firm | Quanta System, S.p.A. |
| Product type | Devices |
| Products | Olympus Sterile Optical Laser Fiber, single use and reusable, Quanta System Sterile Optical Laser Fiber, reusable, Quanta System Sterile Optical Laser Fiber, single use |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product sterility is potentially compromised. |
| Initiation date | Apr 27, 2021 |
| Report date | Jun 16, 2021 |
| Termination date | Sep 5, 2023 |
| City | Samarate |
| Country | Italy |
| FEI number | 3004378299 |
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: