FDA recall Z-2495-2020
Medtronic Perfusion Systems · Class II · device
Product
Extra corporeal circuit with bio-active surface.
Reason for recall
Affected products failed a sterilization test.
Distribution
Domestic Distribution only to CA and MI.
Key facts
- Status
- Terminated
- Initiation date
- 2018-08-08
- Report date
- 2020-07-15
- Termination date
- 2020-10-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brooklyn Park, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2495-2020