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Nikkiso Ltd - Shizuoka Plant recalls DBB-06 Hemodialysis Delivery System
Recalled January 12, 2022 · FDA recall Z-0456-2022 · Nikkiso Ltd - Shizuoka Plant
Hazard
Device lacks premarket approval. · FDA Class II
Units
781 units
Sold at
Distributed nationwide to NY, MO, WA, CA, and TN.
Description
Device lacks premarket approval.
Product
DBB-06 Hemodialysis Delivery System
Manufacturer(s)
Nikkiso Ltd - Shizuoka Plant
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →