B. Braun recalls Infusomat SPACE PUMP IV Set 15D (model 480263) sold after Sep 25, 2023, due to risk of medication backflow 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 Infusomat SPACE PUMP IV Set 15D (model 480263) because a backcheck valve may 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 might 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.
Healthcare providers using this IV set with electric infusion pumps are most at risk. Patients receiving IV treatments with this specific set could experience medication backflow injuries.
Check for model number 480263 on the product. The set was sold after September 25, 2023, and includes UDI-DI 04046955693931.
Verify the model number and distribution date on the product label.
Reach out to B. Braun Medical for guidance on next steps.
The recall indicates a potential risk of medication backflow, so it is not safe to use without checking the recall status.
Contact B. Braun Medical for specific instructions on how to handle the product.
The product was recalled for all lots distributed after September 25, 2023.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-2396-2024 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-2396-2024 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.