Drug recall
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser…
FDA recall event 93373 · Class II · Spectranetics Corporation
Key facts
| Event ID | 93373 |
|---|---|
| Recall numbers | Z-0509-2024 |
| Recalling firm | Spectranetics Corporation |
| Product type | Devices |
| Products | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect product labeling. Exterior product box label does not match internal pouch label. |
| Initiation date | Nov 15, 2023 |
| Report date | Dec 20, 2023 |
| City | Colorado Springs |
| State | CO |
| Country | United States |
| FEI number | 3007284006 |
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: