FDA recall Z-1247-2021
Medtronic Vascular · Class II · device
Product
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Reason for recall
Sterility may be compromised due to an unsealed pouch
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2021-01-15
- Report date
- 2021-03-17
- Termination date
- 2023-06-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Danvers, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2021