Fresenius recalls NaturaLyte Liquid Acid concentrate bottles (Model 08-2351-8) used with hemodialysis machines due to low sodium/calcium levels. Affected lots include 20LXAC097 and 20NXAC033.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius is recalling NaturaLyte Liquid Acid concentrate bottles that may have sodium and calcium levels below what's needed for hemodialysis. This could lead to improper treatment and health risks for patients using these bottles in kidney machines.
The bottles may have sodium and calcium levels too low for proper hemodialysis treatment. This could cause imbalances in the patient's blood, potentially leading to health issues if the treatment isn't adjusted correctly.
Patients using Fresenius hemodialysis machines with these specific NaturaLyte bottles are affected. Those with kidney failure requiring dialysis are most at risk.
Check for Model Number 08-2351-8 bottles used with Fresenius Renal Technologies Sodium Bicarbonate Concentrate. Affected lots include 20LXAC097 and 20NXAC033 (as of March 17, 2021).
Look for Model Number 08-2351-8 on the bottle label.
Reach out to Fresenius Medical Care for assistance with affected lots or replacement options.
The recall states the sodium and calcium levels may be below specifications, so they are not recommended for use without checking with Fresenius.
Affected lots include 20LXAC097 and 20NXAC033 (as of March 17, 2021).
The recall does not specify a stop-use instruction; you should contact Fresenius for guidance.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0817-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0817-2021 from Fresenius. 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.
