B. Braun Medical recalls Infusomat UNIV 15 Drop Pump Set with potential backflow of medication causing patient injuries. All units distributed after August 2, 2:00 PM, 2023 are affected.
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 15 Drop Pump Set units that could allow medication to flow backward from secondary IV containers into primary containers, risking patient injuries. This is a serious hazard that requires immediate attention to prevent adverse drug reactions or medication loss.
The backcheck valve in the pump set might malfunction, causing medication from secondary IV containers to flow backward into primary containers. This can lead to patients experiencing adverse drug reactions or losing medication/blood due to the pump's inability to prime properly.
Healthcare professionals using the Infusomat UNIV 15 Drop Pump Set for intravenous medication administration are most at risk. Patients receiving IV treatments with this pump set could be affected if the backflow occurs.
Check for the model number 363030 on the pump set. Units distributed after August 2, 2023 are affected. The product is used with electrically-powered infusion pumps for IV medication administration.
Immediately stop using the Infusomat UNIV 15 Drop Pump Set if it was distributed after August 2, 2023.
The model number is 363030.
Units distributed after August 2, 2023 are affected.
The pump could allow medication to flow backward from secondary IV containers into primary containers, causing patient injuries like adverse drug reactions or medication loss.
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-2386-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-2386-2024 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.