Skip to content

Bicarby recallZ-2401-2026 · Fresenius Medical Care Holdings, Inc. · initiated May 7, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

On 5/7/2026 an URGENT MEDICAL DEVICE RECALL letters were sent to customers. At this time, FMCRTG is providing this recall notice to alert you of the potential risks associated with the labeling error, and to ask that you identify, segregate, and discontinue use of affected lots, 25SG06026 and 25SG06027, of RFP-400-G Bicarby Dialysate. FMCRTG is requiring the return of the affected Bicarby Dialysate lots. FMCRTG will replace all remaining stock of affected product lots. For product technical questions or concerns, please contact Technical Support at 1-800-323-2732 or Customer Support at 1-800-323-5188 between 8:30AM 4:30PM Eastern Daylight Time. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.

Recall details

Recall number
Z-2401-2026
Status
Open, Classified
Initiated by the company
May 7, 2026
Posted by the FDA
Jun 11, 2026
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
4752
Product code
KPO
FDA submissions
K243786
Distribution
Domestic: TX.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K243786 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page