Drug recall
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
FDA recall event 87284 · Class II · Medtronic Vascular
Key facts
| Event ID | 87284 |
|---|---|
| Recall numbers | Z-1245-2021, Z-1246-2021, Z-1247-2021, Z-1248-2021 |
| Recalling firm | Medtronic Vascular |
| Product type | Devices |
| Products | Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30, Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375, Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35, Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sterility may be compromised due to an unsealed pouch |
| Initiation date | Jan 15, 2021 |
| Report date | Mar 17, 2021 |
| Termination date | Jun 15, 2023 |
| City | Danvers |
| State | MA |
| Country | United States |
| FEI number | 1220452 |
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: