B. Braun Medical recalls Infusomat SPACE PUMP IV sets with backcheck valve that may cause medication backflow, risking patient injury. Affected units distributed after August 1, 2:00 PM, 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 SPACE PUMP IV sets that could allow medication to flow backward into the main IV line, potentially causing patient injuries. This risk exists because the backcheck valve might malfunction, leading to medication backflow or inability to prime the IV line.
The backcheck valve in the IV set may fail to prevent medication from flowing backward from secondary IV containers into the primary IV line. This can cause medication backflow, leading to adverse drug reactions or product malfunction, which might result in loss of medication or blood.
Healthcare providers using the Infusomat SPACE PUMP IV set with the backcheck valve (model 490103) for intravenous medication administration. Patients receiving IV treatments with this specific set are at risk if the valve malfunctions.
Check for the model number 490103 on the Infusomat SPACE PUMP IV set. Units distributed after August 1, 2023, are affected. The set includes a backcheck valve (CKVLV) used with an electrically-powered infusion pump.
Look for the model number 490103 on the Infusomat SPACE PUMP IV set.
Contact B. Braun Medical for further assistance if you have the affected model.
The affected model number is 490103.
Units distributed after August 1, 2023.
The set includes a backcheck valve (CKVLV) used with an electrically-powered infusion pump for intravenous medication administration.
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-2400-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-2400-2024 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.
