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Bicarby Dialysate
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MEDICAL DEVICE RECALLMODERATE

Bicarby Dialysate

Fresenius Medical Care is recalling Bicarby Dialysate due to a GTIN labeling error that may result in the use of an incorrect potassium solution.

What to do

Do not rely solely on the GTIN for product identification. Verify the product code and solution concentration using the lot number and printed labeling on the product bag and case before use.

Posted
Updated
Agency
Firm
Fresenius Medical Care Holdings, Inc.
Recall ID
98892
Status
ONGOING

Why it was recalled

Fresenius Medical Care is recalling Bicarby Dialysate due to a labeling error involving the Global Trade Item Number (GTIN). While the case labeling, lot number, and bag labeling correctly identify the product and solution, the incorrect GTIN could lead to the unrecognized use of a potassium solution with a concentration that differs from the patient's prescription.

Is mine affected?

This recall covers the product below. If you have it, yours is affected.

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

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Editorial summary by Recall Canary · last updated 2026-06-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification