Diasol 100425-10-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 liquid dialysis concentrate product because its safety and effectiveness for dialysis cannot be guaranteed. This affects patients using the product for kidney treatment.

Why it’s dangerous

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

Who’s affected

Patients using this dialysis concentrate for kidney treatment are most at risk. The recall applies to specific units with the lot code PHV08042.

How to tell if you have this one

Check for the product name '100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K' with lot code PHV08042. The UDI is not listed.

Brand
Diasol
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot code PHV08042 on the product label to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall states safety and efficacy cannot be assured, but it does not specify if the product causes injury.

What should I do if I have this product?

The recall does not provide a remedy, so no action is required beyond checking the lot code.

How can I tell if I have the recalled product?

Check for the product name and lot code PHV08042 on the label.

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-0992-2026 — Diasol Diasol

Hello,

I own a Diasol that is covered by recall Z-0992-2026 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-0992-2026 (November 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0992-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K,

Recall notice