Drug recall
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
FDA recall event 90447 · Class II · Surgical Innovations Ltd
Key facts
| Event ID | 90447 |
|---|---|
| Recall numbers | Z-1396-2022 |
| Recalling firm | Surgical Innovations Ltd |
| Product type | Devices |
| Products | YelloPort Elite Universal Seal. For use in laparoscopic procedures. |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product. |
| Initiation date | Jun 2, 2022 |
| Report date | Jul 27, 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: