FDA recall Z-1542-2021
ROi CPS LLC · Class II · device
Product
Regard Dressing Change Tray
Reason for recall
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Distribution
US Nationwide distribution in the state of Louisiana.
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-26
- Report date
- 2021-05-19
- Termination date
- 2023-01-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2021