Diasol recalls 100220-10-DEX100 liquid dialysis concentrate due to unverified safety and efficacy. Affected units have specific lot codes and UDI.
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol is recalling a specific liquid dialysis concentrate product because its safety and effectiveness cannot be guaranteed. This affects patients using the product for dialysis treatments.
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.
Patients using this dialysis concentrate for treatment are most at risk. The recall applies to specific lot codes of the product.
Check for lot codes PHV08112 or PHV10082 on the product label. The product is a liquid concentrate for bicarbonate dialysis with specific volume and concentration.
Look for lot codes PHV08112 or PHV10082 on the product label.
The recall states safety and efficacy cannot be assured, so it is not safe to use.
The recall does not specify a remedy, so check with the manufacturer for guidance.
Look for lot codes PHV08112 or PHV10082 on the product label.
We’ve drafted a message you can send Diasol to request your refund or repair — edit it as you like.
Subject: Recall Z-0989-2026 — Diasol Diasol Hello, I own a Diasol that is covered by recall Z-0989-2026 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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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.