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

FDA device recall Z-2321-2026 · posted 2026-06-05 · Open, Classified

Recall details

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.

Action taken

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.

Root cause

Process design

Status

Open, Classified

Product code

KPO

Quantity affected

1,756,108 units

Distribution

US Nationwide distribution in the states of NY, TN and TX.

Date initiated

2026-05-12

Date posted

2026-06-05

Location

Waltham, MA

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