FDA recall Z-1295-2022
ROi CPS LLC · Class II · device
Product
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Reason for recall
A nonsterile component was packaged in a sterile convenience kit.
Distribution
US Nationwide distribution in the state of FL.
Key facts
- Status
- Terminated
- Initiation date
- 2022-05-20
- Report date
- 2022-07-06
- Termination date
- 2023-05-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2022