Official recall record
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-05-12
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00840861102839
- Brand on record
- Fresenius Medical Care Holdings, Inc.
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-09-16.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-05-07 · US FDA — Medical Devices
Bicarby Dialysate; Model number: RFP-400-G;
Other recalls from this brand
- 2026-05-07 · US FDA — Medical Devices
Bicarby Dialysate; Model number: RFP-400-G;