B. Braun Medical recalls Infusomat 60 pump sets made after September 5, 2:2023 due to potential medication backflow into IV lines, risking patient injury. Affected units have model 363010 and UDI-DI 04046964294174.
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 60 pump sets made after September 5, 2023, because a faulty backcheck valve might cause medication to flow backward into the main IV line, potentially causing patient injuries. This could lead to adverse drug reactions or medication loss.
The backcheck valve in the pump set might fail, allowing medication from a secondary IV container to flow back into the primary IV container. This could cause medication to be lost or lead to adverse drug reactions in patients.
Healthcare professionals using the Infusomat 60 pump set for intravenous medication administration are most at risk. Patients receiving IV treatments with this pump set could be affected if the valve malfunctions.
Check for model number 363010 and UDI-DI 04046964294174 on the pump set. The recall applies to all units distributed after September 5, 2023.
Look for model number 363010 and UDI-DI 04046964294174 on the pump set.
The model number is 363010.
The recall applies to all units distributed after September 5, 2023.
Medication could flow backward into the primary IV container, 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-2385-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-2385-2024 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.
