B. Braun recalls Infusomat UNIV 15 Drop Pump Set (model 363421) sold after August 1, 2:15, 2023. Potential for medication backflow causing patient injuries. Stop using immediately.
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 UNIV 15 Drop Pump Set models sold after August 1, 2023. The backcheck valve may malfunction, causing medication to flow backward into the primary IV container and potentially causing patient injuries.
The backcheck valve in the pump set may fail, allowing medication from a secondary IV container to flow backward into the primary IV container. This can cause medication to be administered incorrectly, leading to adverse drug reactions or loss of medication/blood.
Healthcare professionals using the Infusomat UNIV 15 Drop Pump Set for IV medication administration. Patients receiving IV treatments with this pump set are at risk of medication backflow injuries.
Look for the Infusomat UNIV 15 Drop Pump Set with model number 363421. The product was distributed after August 1, 2023. It is used with electrically-powered IV pumps for medication administration.
Discontinue use of the Infusomat UNIV 15 Drop Pump Set if it was purchased after August 1, 2023.
The model number is 363421.
The product was distributed after August 1, 2023.
The backcheck valve may malfunction, causing medication to flow backward into the primary IV container and potentially causing patient injuries.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-2388-2024 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-2388-2024 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.
