FDA recall Z-1213-2022
Abbott · Class II · device
Product
FIRMap" Catheter, 60mm Basket
Reason for recall
Incorrect product labeling.
Distribution
US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-28
- Report date
- 2022-06-08
- Termination date
- 2024-06-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plymouth, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2022