FDAMay 12, 2026device

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

fresenius medical carefreseniusfresenius medical

UPCs

008408611028390084086110285300840861102822008408611029140084086110284600840861102945

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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