B Braun Medical recalled 100 IV administration sets on October 29, 2025, due to a backflow risk. The recall affects gravity IV and pump administration sets used with several infusion pumps. The potential for medication backflow poses a serious health risk to patients.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled products include the ADDitIV utilized in gravity IV administration sets and pump administration sets for the Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The affected catalog number is 352447. These products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
These IV administration sets may allow for the backflow of medication from secondary IV containers into primary IV containers. This situation can lead to medication errors and unintended drug delivery, which can be dangerous for patients.
There have been no specific reported injuries or deaths due to this issue at this time. However, the risk of medication backflow presents a high hazard level, warranting immediate action.
Stop using the IV administration sets immediately. Follow the recall instructions provided by the manufacturer and contact B Braun Medical Inc or your healthcare provider for further instructions.
For more information, contact B Braun Medical Inc at their official website or by phone. You can also visit the FDA recall page for additional details.
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