Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate

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.

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

On 5/12/2026 an IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers to inform them that manipulation of the luer-lock location during treatment preparation may result in fluid spillage onto the user and floor. This occurs prior to treatment and renders the product unusable. Direct contact with the fluid does not present any risk to the user as frangible manipulation only occurs after the peal seam has been broken and the two fluid compartments have been mixed. The potential risk associated with the affected Bicarby Dialysate product is a slip and fall hazard due to the presence of fluid on the floor.

• FDA enforcement recordOfficial FDA database entry for Z-2321-2026
• FDA 510(k) clearance · K233950The device's official FDA premarket clearance record
• FDA 510(k) clearance · K243786The device's official FDA premarket clearance record
• FDA device classification · KPOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Medical Care Holdings, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.