B. Braun Medical recalled 122,232 IV administration sets sold worldwide through multiple medical distributors. The devices have a backflow risk from secondary (piggyback) IV containers into primary IV containers and may fail to prime. Hospitals and clinics should stop using the sets and follow the manufacturer's recall instructions.
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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This product is an IV administration set used in gravity IV administration and pump-based infusion with BBraun equipment. It is designed to deliver medications through IV lines in clinical settings.
A backflow risk can transfer medication from secondary lines into primary lines, and occlusion may prevent priming. This can disrupt accurate dosing and impede delivery of IV therapies.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics must assess inventory and divert affected sets from use. Facilities may need to replace sets to prevent dosing errors and treatment delays.
Labels on the IV set packaging will display catalog and UDI numbers. Official recall notice and FDA enforcement page provide guidance.
Refunds or replacements, if offered, typically follow the manufacturer’s recall process which may take several weeks.
Keep the recall notice, document lot/catalog numbers, take photos of labels, record dates and correspondence with supplier
Catalog Number: 490225 Primary UDI-DI: 04046964304248 Unit of Dose UDI-DI: 04046964304231 Expiration: Earliest Exp of Component or 36 months Distribution: Worldwide distribution including US, Canada, Germany, Guatemala, and Singapore Sold at: Multiple medical distributors (unknown retailers)
No injuries or incidents have been reported.
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