B. Braun Medical recalls Infusomat UNIV 60 drop pump sets with potential for medication backflow into primary IV containers, risking patient injury. Affected units distributed after August 1, 2023.
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 Medical is recalling Infusomat UNIV 60 drop pump sets that could allow medication to flow backward into the main IV line, causing patient injuries. This risk occurs when the backcheck valve malfunctions, which might happen during use with an electric infusion pump.
The backcheck valve in the pump set can malfunction, causing medication from secondary IV containers to flow backward into the primary IV line. This may lead to patient injuries such as adverse drug reactions or loss of medication/blood due to improper priming of the pump.
Healthcare professionals using the Infusomat UNIV 60 drop pump set with electric infusion pumps for IV medication administration. Patients receiving IV treatments with this pump set are at risk if the backcheck valve fails.
Check for the model number 490104 on the pump set. Units distributed after August 1, 2023 are affected. The product is used with electric infusion pumps for intravenous medication delivery.
Look for model number 490104 on the Infusomat UNIV 60 drop pump set.
Reach out to B. Braun Medical for guidance on next steps if the pump set is affected.
The affected model number is 490104.
Units distributed after August 1, 2023 are affected.
Medication could flow backward into the primary IV line, causing patient injuries like adverse drug reactions or loss of medication/blood.
We’ve drafted a message you can send B. Braun Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2401-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-2401-2024 from B. Braun Medical. 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.
