Z-3091-2026Class II

GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate...

Name: Z-3091-2026 GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate...
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2026-07-14
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2026-07-14 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis on 2026-07-14. The reason FDA records is "Complaints of blue-green discoloration in product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3091-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-14
Posted: 2026-09-03
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Complaints of blue-green discoloration in product
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Fresenius Medical Care issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/15/2026 via USPS first class mail. The notice explained the issue, potential risk and requested the following action: "1. Identify if you have any affected product lots on hand. 2. IMMEDIATELY segregate and discontinue use of affected lots. 3. Contact FMCRTG (1-833-203-5448) between 8:00 AM 8:00 PM Eastern daily, for return of affected lots and replacement of your stock. 4. Complete and return the attached REPLY FORM." For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Quantity in commerce: 27,216 cs; 2,316 ea
Distribution: Worldwide distribution - US Nationwide and the country of Mexico.
Product codes and lots: 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3091-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3091-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3092-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3093-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03

Product code KPO

K192209Class IICitrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC / cleared 2020-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)