Leventon recalls two models of DOSI-FUSER 12591 infusion pumps for misbranding without 510(k) clearance. These pumps must be removed from use to prevent potential safety risks.
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Leventon is recalling two specific infusion pump models because they lack proper regulatory clearance. This means they are misbranded and must be taken out of the market to avoid safety issues.
The pumps are misbranded because they do not have the required 510(k) clearance from the FDA. This lack of clearance means they were not properly tested or approved for use in the U.S. market, which could lead to safety concerns.
Healthcare providers using these pumps for patient drug infusions are affected. Patients receiving treatments through these pumps face the highest risk.
Check for the model numbers 12591 5-500D1 or 12591 5-600D1 on the pump. These pumps were sold in the U.S. with specific identifiers like 08436020767470 or 08436020768026.
Identify if your pump has the model numbers 12591 5-500D1 or 12591 5-600D1.
The pumps lack 510(k) clearance, making them misbranded and requiring removal from the U.S. market.
The official notice does not specify a remedy, so you should check with Leventon directly.
The recall indicates they are not approved for use in the U.S. market, so they should not be used.
We’ve drafted a message you can send Leventon to request your refund or repair — edit it as you like.
Subject: Recall Z-2360-2019 — Leventon Leventon Hello, I own a Leventon that is covered by recall Z-2360-2019 from Leventon. 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.
