FDA recall Z-0620-2024

ROi CPS LLC · Class I · device

Product

regard Operative LAP, Item Number 800943001; surgical convenience kit

Reason for recall

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

Distribution

US distribution to Louisiana

Key facts

Status
Terminated
Initiation date
2023-12-18
Report date
2024-01-24
Termination date
2024-10-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0620-2024