FDA recall Z-0949-2022
Terumo Cardiovascular Systems Corp · Class II · device
Product
Cardiovascular Procedure Kit catalog # 76645 & 73806
Reason for recall
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Distribution
US Nationwide distribution in the states of CA and IN.
Key facts
- Status
- Terminated
- Initiation date
- 2022-02-03
- Report date
- 2022-04-27
- Termination date
- 2024-02-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Ashland, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2022