B. Braun recalls Infusomat SPACE PUMP IV sets 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 is recalling Infusomat SPACE PUMP IV sets that could allow medication to flow backward into the main IV line, risking patient injuries. This recall affects units distributed after August 2, 2023.
The backcheck valve might fail, causing medication from secondary IV containers to flow back into the primary IV line. This can lead to medication mix-ups, inability to prime the IV line, and potential patient injuries.
Healthcare providers using the Infusomat SPACE PUMP IV sets for intravenous medication administration are most at risk. Patients receiving IV treatments with these sets could face adverse reactions.
Check for the model number 363420 on the product. The recall includes all units distributed after August 2, 2023.
Look for the model number 363420 and distribution date after August 2, 2023.
The recall states the product could malfunction, so it is not safe to use without checking the recall details.
The recall does not specify a remedy, so contact B. Braun Medical for guidance.
The recall applies to units distributed after August 2, 2023.
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-2387-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-2387-2024 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.
