FDA-Device2022-01-12Class II
DBB-06 Hemodialysis Delivery System
Nikkiso Ltd - Shizuoka Plant
Hazard
Device lacks premarket approval.
Sold states
Distributed nationwide to NY, MO, WA, CA, and TN.
Affected count
781 units
Manufactured in
498 1, Shizutani; Shizuoka-Ken, Makinohara, N/A, Japan
Products
DBB-06 Hemodialysis Delivery System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0456-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief