FDA recall Z-0456-2022
Nikkiso Ltd - Shizuoka Plant · Class II · device
Product
DBB-06 Hemodialysis Delivery System
Reason for recall
Device lacks premarket approval.
Distribution
Distributed nationwide to NY, MO, WA, CA, and TN.
Key facts
- Status
- Ongoing
- Initiation date
- 2021-11-24
- Report date
- 2022-01-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Makinohara, N/A, Japan
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0456-2022