Fresenius Medical Care recalls NaturaLyte Dry Bicarbonate Concentrate due to potential freezing in refrigerated trucks. This could affect dialysis treatments. Check lot numbers for affected units.
Exposed to freezing temperatures due to refrigerated truck malfunctions
Fresenius Medical Care is recalling NaturaLyte Dry Bicarbonate Concentrate because refrigerated trucks may have malfunctioned, causing the product to freeze. This poses a risk to dialysis patients who use the concentrate in their treatment.
The concentrate can freeze if refrigerated trucks malfunction, which may alter its chemical properties. This could affect the dialysis treatment process if the concentrate is not properly prepared for use.
Dialysis patients using NaturaLyte Dry Bicarbonate Concentrate for hemodialysis are most at risk. The product is used in specific 45X proportioning systems for dialysis treatment.
Check the lot number on the product label. Affected units have lot number 21ATBC004 and UDI (Unique Device Identifier) 0100840861101955.
Look for lot number 21ATBC004 or UDI 0100840861101955 on the product label.
The product may have frozen due to refrigerated truck malfunctions, which could affect dialysis treatments.
Check the lot number on the product label. Affected units have lot number 21ATBC004 and UDI 0100840861101955.
The recall does not specify a remedy, so contact Fresenius Medical Care for further instructions.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-2087-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2087-2021 from Fresenius Medical Care. 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.
