FDA recall Z-2066-2020
Baxter Healthcare Corporation · Class II · device
Product
Prismaflex Control Unit
Reason for recall
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Distribution
Distribution only to Puerto Rico and Guam
Key facts
- Status
- Terminated
- Initiation date
- 2020-04-07
- Report date
- 2020-05-27
- Termination date
- 2021-11-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2066-2020