FDA recall Z-1602-2023
Surgical Innovations Ltd · Class II · device
Product
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Reason for recall
Optical Trocars sterility assurance can not be guaranteed
Distribution
US: MA OUS: None
Key facts
- Status
- Ongoing
- Initiation date
- 2023-03-28
- Report date
- 2023-05-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Leeds, N/A, United Kingdom
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1602-2023