Medivators recalls dialysate concentrate for hemodialysis due to potential manufacturing issues that could lead to improper formulation. Affected lots may not meet specifications for safe use in hemodialysis machines.
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Medivators is recalling dialysate concentrate for hemodialysis that may have been improperly formulated during manufacturing. This could affect the safety and effectiveness of the treatment if used in hemodialysis machines.
The concentrate may have been improperly formulated during manufacturing, leading to a product that doesn't meet the required specifications. This could affect the safety and effectiveness of the hemodialysis treatment if used in the machine.
Hemodialysis patients using Medivators dialysate concentrate with lot number 489224 are affected. Patients using this product for kidney treatment are most at risk.
Check for the lot number 489: 489224 on the dialysate concentrate container. This product is used with bicarbonate in hemodialysis machines for kidney treatment.
Look for lot number 489224 on the dialysate concentrate container.
Medivators is recalling dialysate concentrate for hemodialysis that may have been improperly formulated during manufacturing.
Check the lot number on the container. If it's 489224, contact Medivators for instructions.
The recall states there may be an anomaly during manufacturing that could lead to improper formulation, but no specific safety risks are described.
We’ve drafted a message you can send Medivators to request your refund or repair — edit it as you like.
Subject: Recall Z-1859-2021 — Medivators Medivators Hello, I own a Medivators that is covered by recall Z-1859-2021 from Medivators. 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.
