FDA recall Z-1051-2022
ROi CPS LLC · Class II · device
Product
Regard brand CABG Pack A and B - Spartanburg
Reason for recall
Kits were packed into shipping boxes incorrectly.
Distribution
Recall impacted one domestic consignee in NC
Key facts
- Status
- Terminated
- Initiation date
- 2022-03-21
- Report date
- 2022-05-18
- Termination date
- 2023-12-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2022