FDA Class II Recall: Bicarby Dialysate; Model number: RFP-400-G; by Fresenius Medical Care Holdings, Inc.

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Bicarby Dialysate; Model number: RFP-400-G; -- and the recall number Z-2401-2026. If it matches, stop using or distributing it and contact Fresenius Medical Care Holdings, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Fresenius Medical Care Holdings, Inc. and the affected product is described in FDA's record as: Bicarby Dialysate; Model number: RFP-400-G;. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2401-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Fresenius Kabi USA, LLC’s FDA history

Argus HQ has recorded 29 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 27 recalls, 2 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Fresenius Medical Care Holdings, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 29 total FDA actions tied to Fresenius Medical Care Holdings, Inc., including 27 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2401-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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