Recall Z-2401-2026— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2401-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-07

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2026-05-07. It names one FDA 510(k) clearance: K243786. Product: Bicarby Dialysate; Model number: RFP-400-G;. Reason: 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..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-07
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K243786 — Bicarby Dialysate RFP-402 (RFP-402-G) +7 moreFresenius Medical Care Renal Therapies Group, LLC·cleared 2025-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.