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FDA · Medical devices ·

GRANUFLO Dry Acid Concentrate recall

Fresenius Medical Care Renal Therapies Group, LLC recalled GRANUFLO Dry Acid Concentrate on September 9, 2026 because of complaints of blue-green discoloration in product. It was sold nationwide.

Why it was recalled

Complaints of blue-green discoloration in product

What's recalled

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

Quantity: 27,216 cs; 2,316 ea

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide distribution - US Nationwide and the country of Mexico.
Status
Ongoing
Recall number
Z-3091-2026
Source
U.S. Food and Drug Administration

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