Drug recall
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
FDA recall event 93629 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 93629 |
|---|---|
| Recall numbers | Z-0718-2024 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed… |
| Initiation date | Dec 4, 2023 |
| Report date | Jan 24, 2024 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
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: