Reported Jun 17, 2026 · Ongoing
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- Bicarby" Dialysate
- Model Numbers
RFP-400-GRFP-401-GRFP-402-GRFP-404-GRFP-407-Gand RFP-456-G
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Barcodes Product as published RFP-400-G— — 00840861102839UDI-DI: 00840861102839 RFP-401-G— — 00840861102853UDI-DI: 00840861102853 RFP-402-G— — 00840861102822UDI-DI: 00840861102822 RFP-404-G— — 00840861102914UDI-DI: 00840861102914 RFP-407-G— RFP-456-G00840861102846UDI-DI: 00840861102846: 6. — 00840861102945UDI-DI: 00840861102945 — All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026 - Amount recalled
- 1,756,108 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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