FDA recall Z-0187-2022
Queen Comfort Products lLC · Class II · device
Product
COVENA PICC Sleeve
Reason for recall
Marketed without FDA clearance
Distribution
US Nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-18
- Report date
- 2021-11-10
- Termination date
- 2024-05-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waxhaw, NC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2022