FDA recall Z-0837-2022
ROi CPS LLC · Class III · device
Product
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Reason for recall
Recalled devices were packaged in convenience kits.
Distribution
US Nationwide distribution in the state of Missouri.
Key facts
- Status
- Terminated
- Initiation date
- 2022-02-24
- Report date
- 2022-04-06
- Termination date
- 2022-04-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0837-2022