Fresenius Granuflo Dry Acid Concentrate Recall: Discolored Powder Hazard

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Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St, N/A · Waltham, MA 02451-1521

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius is recalling Granuflo Dry Acid Concentrate-3K 2.5 Ca 1 Mg 16.5 GAL for hemodialysis because it contains discolored powder with a foreign substance. This could cause harm if used in dialysis treatments.

Why it’s dangerous

The product contains discolored powder with a confirmed foreign substance. This could lead to contamination or injury during hemodialysis treatments if the product is used as intended.

Who’s affected

Hemodialysis patients using the recalled Granuflo Dry Acid Concentrate-3K 2.5 Ca 1 Mg 16.5 GAL (Lot codes 18BTGF016, 18ETGF006, etc.) are affected. Patients using this product for dialysis are at risk of harm.

How to tell if you have this one

Check for the product name 'Granuflo Dry Acid Concentrate-3K 2.5 Ca 1 Mg 16.5 GAL' with catalog number OFD3251-3B. Look for lot codes 18BTGF016, 18ETGF006, 18ETGF014, 18HTGF015, or 18LTGF003.

Brand
Fresenius
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard the recalled Granuflo Dry Acid Concentrate-3K 2.5 Ca 1 Mg 16.5 GAL product if you have it.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

No, the product contains discolored powder with a foreign substance and should not be used.

What lot codes are affected?

Lot codes 18BTGF016, 18ETGF006, 18ETGF014, 18HTGF015, and 18LTGF003.

How do I know if I have the recalled product?

Check for the product name 'Granuflo Dry Acid Concentrate-3K 2.5 Ca 1 Mg 16.5 GAL' with catalog number OFD3251-3B and the listed lot codes.

Take action

Contact Fresenius

We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0518-2019 — Fresenius Fresenius

Hello,

I own a Fresenius that is covered by recall Z-0518-2019 from Fresenius.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0518-2019 (October 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0518-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

Stop using this now