B. Braun recalls Infusomat UNIV 15 DR Pump Set (model 363424) sold after August 1, 2023, due to potential backflow of medication causing patient injuries.
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
B. Braun is recalling certain Infusomat UNIV 15 DR Pump Sets because a backcheck valve might malfunction, causing medication to flow backward into the primary IV container. This could lead to patient injuries like adverse drug reactions or loss of medication.
The backcheck valve may fail, allowing medication from secondary IV containers to flow back into the primary container. This can cause medication to be lost or lead to adverse reactions in patients.
Patients using the recalled pump sets with intravenous medication administration are at risk. Healthcare providers who use these pumps for IV treatments are most affected.
Check for model number 363424 on the pump set. The product was distributed after August 1, 2023. It is used with electrically-powered IV pumps for medication delivery.
Look for model number 363424 on the pump set label.
Reach out to your healthcare provider for guidance on next steps if you have the recalled pump set.
The model number is 363424.
The product was distributed after August 1, 2023.
Medication could flow backward into the primary IV container, causing patient injuries like adverse drug reactions or loss of medication.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-2391-2024 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-2391-2024 from B. Braun. 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.
