FDA recall Z-1852-2022

Surgical Innovations Ltd · Class II · device

Product

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. 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-1852-2022