Nikkiso Ltd - Shizuoka Plant recalls DBB-06 Hemodialysis Delivery System
- Recall date
- November 24, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0456-2022
- FDA classification
- Class II
- Brand / firm
- Nikkiso Ltd - Shizuoka Plant
- Sold / distributed
- Distributed nationwide to NY, MO, WA, CA, and TN.
Why it was recalled
Device lacks premarket approval.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DBB-06 Hemodialysis Delivery System
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