⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Fresenius Medical Care Holdings, Inc.: Bicarby Dialysate; Model number: RFP-400-G;

Medical DevicesSource: FDA (device) · Date: 2026-06-17

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Medical Care Holdings, Inc.
Product
Bicarby Dialysate; Model number: RFP-400-G;
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Domestic: TX.
Recall initiated
2026-05-07
Code info
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
Product quantity
4752
Voluntary mandated
Voluntary: Firm initiated
City
Waltham
State
MA
Country
United States
Event id
98892
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