CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Bicarby Dialysate recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling Bicarby Dialysate, distributed in Texas. The recall was initiated on 7 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;

Quantity recalled4752

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2401-2026
FDA event ID: 98892
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 7 May 2026
FDA classified: 11 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 May 2026	Recall initiated by company
11 Jun 2026	Classified by FDA	+35 days
17 Jun 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Domestic: TX.

Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Domestic: TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Fresenius Medical Care Holdings

All 165

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
24 Dec 2025Device	CLASS II	5008X CAREsystem +CLiC +CDX recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Device Malfunction	LA, MA, MN

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