Drug recall
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH…
FDA recall event 90801 · Class II · Surgical Innovations Ltd
Key facts
| Event ID | 90801 |
|---|---|
| Recall numbers | Z-1852-2022, Z-1853-2022 |
| Recalling firm | Surgical Innovations Ltd |
| Product type | Devices |
| Products | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures., Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. |
| Initiation date | Jan 20, 2022 |
| Report date | Oct 5, 2022 |
| City | Leeds |
| Country | United Kingdom |
| FEI number | 3002808173 |
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: