FDA recall Z-2401-2026

Product

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

Reason for recall

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.

Distribution

Domestic: TX.

Key facts

Status

Ongoing

Initiation date

2026-05-07

Report date

2026-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2026