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Recall Observatory FDA recall evidence

Device product

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

Z-2401-2026

May 07, 2026

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 98892
Status
Ongoing
Classification
Class II
Quantity
4752
Official record key
device-enforcement:Z-2401-2026

Official wording

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.

Code information: Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;

Distribution pattern: Domestic: TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.