FDA recall Z-1409-2020
Baxter Healthcare Corporation · Class II · device
Product
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Reason for recall
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-11-15
- Report date
- 2020-03-11
- Termination date
- 2020-11-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2020