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

Class II

Recalling firm: Fresenius Medical Care Holdings, Inc.
Reason for recall: 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.
Distribution pattern: US Nationwide distribution in the states of NY, TN and TX.
State: MA
Status: Ongoing
Recall number: Z-2321-2026
Recall initiated: May 12, 2026