Hemodialysis Delivery System distributed without FDA premarket approval
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a high-risk medical device (hemodialysis delivery system) distributed without premarket approval. The rubric classifies this as a 'risk-of-harm product where injury has not yet been reported,' which corresponds to a severity score of 3 (High). Although no injuries have been reported, the device's safety and effectiveness were never verified by FDA review.
Plain-English summary
The DBB-06 Hemodialysis Delivery System, manufactured by Nikkiso Ltd - Shizuoka Plant, was distributed without FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in New York, Missouri, Washington, California, and Tennessee.
FDA premarket approval is required before medical devices can be marketed to ensure they are safe and effective for their intended use.
Healthcare facilities that received the affected units should stop using them and contact the manufacturer or FDA for guidance on proper handling and disposition of the devices.
The recalled product
- Product
- DBB-06 Hemodialysis Delivery System
- Manufacturer
- Nikkiso Ltd - Shizuoka Plant
- Category
- Medical Device — Hemodialysis
- Hazard
- unapproved-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: DBB-06
- Serial Numbers: J1910861
- J1905670
- J1905916
- J1910971
- J1909943
- J1909306
- J1908111
- J1909202
- J1907127
- J1908023
- J1910962
- J1910866
- J1910028
- J1909307
- J1907329
- J1909853
- J1908776
- J1908108
- J1914585
Distribution
Distributed nationwide across the United States.
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