Official recall record
Bicarby Dialysate; Model number: RFP-400-G;
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-05-07
- 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
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
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.
- 2026-05-12 · US FDA — Medical Devices
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Other recalls from this brand
- 2026-05-12 · US FDA — Medical Devices
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;