Fresenius recalls NaturaLyte Liquid Acid concentrate drums (Model 13-2201-5) used in hemodialysis machines due to low sodium/calcium levels. Affected units have specific lot numbers.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius is recalling NaturaLyte Liquid Acid concentrate drums that may have sodium and calcium levels below what's needed for hemodialysis. This could affect the safety of the treatment process if used in kidney machines.
The concentrates may have sodium and calcium levels below the required manufacturing standards. This could lead to improper dialysis treatment if the machine uses these concentrates without sufficient levels.
Patients using hemodialysis machines with Fresenius Renal Technologies Sodium Bicarbonate Concentrate are likely affected. Those with the specific lot numbers of the NaturaLyte drums are at risk.
Check for the model number 13-2201-5 on the drums. Affected units have lot numbers: 20LXAC030, 20LXAC084, 20NXAC002, 20LXAC014, or 20NXAC018.
Look for lot numbers 20LXAC030, 20LXAC084, 20NXAC002, 20LXAC014, or 20NXAC018 on the drums.
The sodium and calcium levels in these concentrates were below the manufacturing specifications, which could affect hemodialysis treatment safety.
Check the lot number on the drum. If it matches the affected numbers, contact Fresenius for guidance.
The recall record does not mention a remedy or fix, so no action is required beyond checking the lot number.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0824-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0824-2021 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.
