Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 17, 2026

Bicarby Dialysate

Full official product description

Bicarby Dialysate; Model number: RFP-400-G;

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 1, 2026, 11:43 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Bicarby Dialysate; Model number: RFP-400-G;

Identifiers to compare

  • UDI 00840861102839
  • Model RFP-400-G
  • Lot codes
  • Lot 25SG06027
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Bicarby Dialysate; Model number: RFP-400-G;Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;4752Z-2401-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Domestic: TX.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.