Drug recall
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
FDA recall event 91328 · Class II · Medtronic Navigation, Inc.
Key facts
| Event ID | 91328 |
|---|---|
| Recall numbers | Z-0953-2023 |
| Recalling firm | Medtronic Navigation, Inc. |
| Product type | Devices |
| Products | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. |
| Initiation date | Dec 8, 2022 |
| Report date | Jan 18, 2023 |
| City | Louisville |
| State | CO |
| Country | United States |
| FEI number | 1000517638 |
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: