FDA recall Z-1407-2022

ROi CPS LLC · Class II · device

Product

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

Reason for recall

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Distribution

Distribution was made to MO. There was no foreign/military/government distribution.

Key facts

Status
Terminated
Initiation date
2022-06-03
Report date
2022-07-27
Termination date
2023-04-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2022