B. Braun Medical recalled 58,752 Anesthesia IV Sets used with Infusomat Space pumps and other BBMI devices. The recall targets backflow from secondary piggyback IV containers to primary containers and occlusion. Hospitals and clinicians should stop using the device immediately and await manufacturer guidance by recall letter.
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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Anesthesia IV Sets are used with gravity or pump-based IV administration systems to deliver medications in hospital settings.
A backflow from secondary to primary IV containers could result in incorrect dosing or contamination, and occlusion could prevent priming of the line.
This recall is not a broader industry pattern.
Hospitals may need to halt IV therapy using the affected sets, potentially delaying treatments and requiring administrative work to switch to safe alternatives.
Codes are printed on the product packaging and labels. The FDA recall page provides additional identifiers and instructions.
Not specified in the recall notice; replacement timelines vary by institution.
Keep the recall letter, product labels, catalog numbers, UDIs, and all correspondence as part of your incident file.
Catalog Number: 490468. Primary UDI-DI: 04046964958793. Unit of Dose UDI-DI: 04046964958786. Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore). Recall Date: 2025-10-29.
No injuries or incidents have been reported.
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