B. Braun Medical recalled 129,480 IV Administration Sets sold worldwide to hospitals and clinics. The devices can backflow from secondary piggyback IV containers into primary containers and cannot be primed, risking incorrect dosing. Hospitals and healthcare providers should stop using the devices immediately and follow the recall instructions from B. Braun Medical.
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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IV administration sets are used to deliver fluids and medications through a patient’s IV line. They connect to piggyback and primary IV containers and include a drip chamber and connectors. These devices are common in hospitals and clinics.
Backflow from a secondary piggyback container into the primary line can contaminate or alter the dose. The inability to prime creates the risk that the line will not deliver the intended fluid or medication.
This recall is not identified as part of a broader industry pattern.
The recall affects a large quantity of devices used daily in patient care. Hospitals may need to halt use of affected lots and coordinate replacements, potentially impacting treatment schedules and supply chains.
Identify packaging labels and device documentation for catalog numbers and UDIs. Refer to the FDA recall page for guidance.
Remediation timelines vary by institution. Replacement units and instructions are typically coordinated within 4-8 weeks.
Document recall notice, catalog numbers, and UDIs in asset-tracking systems. Save correspondence with the manufacturer. Photograph affected packaging and keep samples if allowed.
Catalog Numbers: 490242; 490311; 490353. Primary UDI-DI: 04046964716461; Unit of Dose UDI-DI: 04046964716454. Catalog Number 490311: Primary UDI-DI 04046964539688; Unit of Dose UDI-DI 04046964525629. Catalog Number 490353: Primary UDI-DI 04046964602368; Unit of Dose UDI-DI 04046964602351. Distribution: Worldwide, including US, Canada, Germany, Guatemala, and Singapore. Recall Date: 2025-10-29. Quantity: 129,480 units. Sold to healthcare facilities worldwide.
No injuries or incidents have been reported.
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