Recall Z-0456-2022— Nikkiso Ltd - Shizuoka Plant
Class II · Ongoing
Class II FDA medical device recall by Nikkiso Ltd - Shizuoka Plant, initiated 2021-11-24. It names 2 FDA 510(k) clearances: K152938, K091978. Product: DBB-06 Hemodialysis Delivery System. Reason: Device lacks premarket approval..
- Recalling firm
- Nikkiso Ltd - Shizuoka Plant
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-24
- Firm location
- Makinohara, N/A, Japan
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DBB-06 Hemodialysis Delivery System
Reason for recall
Device lacks premarket approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.