FDA recall Z-1853-2022
Surgical Innovations Ltd · Class II · device
Product
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Reason for recall
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Distribution
US: MA
Key facts
- Status
- Ongoing
- Initiation date
- 2022-01-20
- Report date
- 2022-10-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Leeds, N/A, United Kingdom
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1853-2022