DBB-06 Hemodialysis Delivery System
Reported: January 12, 2022 Initiated: November 24, 2021 #Z-0456-2022
Product Description
DBB-06 Hemodialysis Delivery System
Reason for Recall
Device lacks premarket approval.
Details
- Recalling Firm
- Nikkiso Ltd - Shizuoka Plant
- Units Affected
- 781 units
- Distribution
- Distributed nationwide to NY, MO, WA, CA, and TN.
- Location
- Makinohara, N/A
Frequently Asked Questions
What product was recalled? ▼
DBB-06 Hemodialysis Delivery System. Recalled by Nikkiso Ltd - Shizuoka Plant. Units affected: 781 units.
Why was this product recalled? ▼
Device lacks premarket approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 12, 2022. Severity: Moderate. Recall number: Z-0456-2022.
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