Diasol 100325-10-DEX100 Dialysis Concentrate Recall: Safety Efficacy Concerns

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Contact the company & request your remedy

Recalling firmDiasol, Inc310 S 43rd Ave Ste B, N/A · Phoenix, AZ 85009-4606

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Diasol is recalling a specific batch of liquid bicarbonate dialysis concentrate because its safety and effectiveness cannot be guaranteed. This affects patients using the product for dialysis treatments.

Why it’s dangerous

The product's safety and effectiveness cannot be assured, meaning it might not work properly or could cause harm during dialysis. This is a critical issue for patients relying on the concentrate for treatment.

Who’s affected

Patients using the recalled dialysis concentrate for treatment are most at risk. The product is used in medical settings for kidney failure management.

How to tell if you have this one

Check the lot code on the product label, which should be one of PHV07221 through PHV10071. The product is a liquid concentrate for bicarbonate dialysis used in medical treatments.

Brand
Diasol
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Diasol, Inc for specific instructions on how to handle the recalled product.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states that the safety and efficacy of the dialysis concentrate cannot be assured, so it is not recommended for use.

What lot codes are affected?

The affected lot codes are PHV07221 through PHV10071.

How can I check if I have the recalled product?

Look for the lot code on the product label, which should be one of PHV07221 through PHV10071.

Take action

Contact Diasol

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

✉️ Open in email

Subject: Recall Z-0991-2026 — Diasol Diasol

Hello,

I own a Diasol that is covered by recall Z-0991-2026 from Diasol.

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-0991-2026 (November 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0991-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.

Diasol, Inc recalls Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K,

Recall notice