Fresenius Medical Care recalls Bicarby dialysate models RFP-400-G to RFP-456-G due to potential leaks causing slip and fall hazards. Affected units were produced from January 2025 to January 2026.
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
Fresenius Medical Care is recalling specific Bicarby dialysate models because leaks during setup could cause slippery floors and slip/fall injuries. This affects dialysis patients and healthcare workers using these products.
The dialysate can leak during preparation, creating slippery floors. This increases the risk of slips and falls, which could lead to injuries for people using the product.
Dialysis patients and healthcare workers using the recalled Bicarby dialysate models are most at risk due to potential leaks causing slippery floors and slip/fall injuries.
Check for model numbers RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, or RFP-456-G. These units were produced from January 13, 2025, through January 13, 2026.
Identify if your dialysate has one of the model numbers RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, or RFP-456-G.
If you notice leaks during preparation, stop using the dialysate immediately to prevent slips and falls.
The recall is due to increased reports of leaks during dialysate preparation, which could cause slippery floors and slip/fall injuries.
Models RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G.
These units were produced from January 13, 2025, through January 13, 2026.
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-2321-2026 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2321-2026 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.
