Fresenius Medical Care Holdings, Inc.: Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Recall Summary Fresenius Medical Care is recalling Bicarby dialysate concentrate (used in hemodialysis treatment) in six specific model numbers because the luer-lock connections are leaking when the product is being prepared for use. The leaking fluid can create a slip and fall hazard on floors. This recall affects dialysis patients and facilities across the United States.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Product: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Reason: 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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-05-12
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: US Nationwide distribution in the states of NY, TN and TX.

Recall details on Nibble Recalls: https://trynibble.app/recalls/ca390820-d81d-46db-b9d5-3422bc62e848