B. Braun recalls Infusomat UNIV 15 Drop Pump Set W3 CareSite L.L. after potential backflow of medication causing patient injuries. All units distributed after August 1, 2.023 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 is recalling its Infusomat UNIV 15 Drop Pump Set W3 CareSite L.L. because a backcheck valve malfunction could cause medication to flow backward into the primary IV container, potentially causing patient injuries. This risk affects patients receiving IV medication through this pump set.
The backcheck valve may malfunction, allowing medication from secondary IV containers to flow back into the primary container. This can cause medication to not be properly primed, leading to patient injuries such as adverse drug reactions or loss of medication.
Patients using this pump set for intravenous medication administration are most at risk. The recall applies to all units distributed after August 1, 2023.
Check for the model number 490100 on the pump set. Units distributed after August 1, 2023 are affected. The product is used with electrically-powered IV pumps for medication delivery.
Look for the model number 490100 and distribution date after August 1, 2023 on the pump set.
The recall states that the backcheck valve may malfunction, causing medication backflow and patient injuries. Using the pump set as intended could pose a risk.
The recall does not specify a remedy, so contact B. Braun Medical for guidance on next steps.
Check for the model number 490100 and distribution date after August 1, 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-2397-2024 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-2397-2024 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.