FDA recall Z-0985-2025
Medtronic Perfusion Systems · Class II · device
Product
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Reason for recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Distribution
Worldwide - US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-12-12
- Report date
- 2025-01-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brooklyn Park, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2025