Nikkiso recalls DBB-06 Hemodialysis Delivery Systems with serial numbers listed. Device lacks premarket approval, posing potential safety risks. Consumers should stop using affected units immediately.
Device lacks premarket approval.
Nikkiso is recalling DBB-06 Hemodialysis Delivery Systems that lack premarket approval. This means the device hasn't been approved by the FDA for safety before being sold, which could lead to health risks for users.
The device lacks premarket approval, meaning it hasn't been tested or approved by the FDA for safety before being sold. This could lead to health risks such as complications during dialysis treatments if the device malfunctions.
People using the DBB-06 Hemodialysis Delivery System with the listed serial numbers are affected. Patients undergoing dialysis are most at risk due to the device's critical medical purpose.
Check if your DBB-06 Hemodialysis Delivery System has a serial number from the list provided in the recall notice. The device was sold by Nikkiso Ltd - Shizuoka Plant.
Immediately stop using the DBB-06 Hemodialysis Delivery System if it has a serial number listed in the recall.
The device lacks premarket approval, meaning it hasn't been approved by the FDA for safety before being sold.
Check if your DBB-06 Hemodialysis Delivery System has a serial number from the list provided in the recall notice.
Immediately stop using the device and contact Nikkiso for further instructions.
We’ve drafted a message you can send Nikkiso to request your refund or repair — edit it as you like.
Subject: Recall Z-0456-2022 — Nikkiso Nikkiso Hello, I own a Nikkiso that is covered by recall Z-0456-2022 from Nikkiso. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
