B. Braun recalls Infusomat SPACE PUMP IV sets (model 480255) sold after September 6, 2:30 PM, 2023, due to potential backflow of medication causing patient injuries.
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 SPACE PUMP IV sets made after September 6, 2023, because a faulty backcheck valve might cause medication to flow backward into the main IV line, risking patient injury. This could lead to adverse drug reactions or loss of medication.
The backcheck valve in the IV set can malfunction, allowing medication from secondary IV containers to flow back into the primary IV line. This can cause medication to be lost or lead to adverse reactions in patients.
Healthcare professionals using the Infusomat SPACE PUMP IV set with an electric infusion pump for IV medication administration are most at risk. Patients receiving IV treatment with this specific set may also be affected.
Check for the model number 480255 on the Infusomat SPACE PUMP IV set. The product was distributed after September 6, 2023, and includes the UDI-DI code 04046955324804.
Identify the model number (480255) and distribution date (after September 6, 2023) to confirm if the set is recalled.
The recall is for healthcare professionals using the IV set; patients receiving treatment with the recalled set may be affected.
A malfunctioning backcheck valve could cause medication to flow backward into the primary IV line, potentially leading to adverse drug reactions or loss of medication.
Look for the model number 480255 and distribution date after September 6, 2023, on the product label.
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-2395-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-2395-2024 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.
