B. Braun Medical has issued an active recall for 45,288 IV administration sets catalog 490412. The devices support gravity and pump-based IV administration with Infusomat Space, Outlook, and Vista Basic Pumps. The recall cites a design defect that can allow backflow from secondary piggyback containers into primary IV lines and prevent priming.
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 IV administration set is used to deliver medications through gravity or pump-assisted IV systems. It connects to both primary and secondary IV lines and is designed for use in hospital or clinical settings.
A backflow from a secondary (piggyback) container into the primary IV line can lead to incorrect dosing. The incapacity to prime the line increases the risk of incomplete or delayed medication delivery, potentially harming patients.
This recall is not described as part of a broader industry pattern in the provided data.
Healthcare providers must halt use of the affected sets to prevent potential medication errors. Hospitals may need to switch to alternative IV sets, impacting inventory and workflow.
Check the FDA enforcement page for Z-0692-2026 and the manufacturer’s recall notification for 490412.
No specific refund/replacement timeline provided. Typical recall remediation may take several weeks.
Keep the recall notice, labeling, UDIs, serials, and correspondence. Photograph packaging and labeling for records
Catalog Number: 490412 Primary UDI-DI: 04046964797989 Unit of Dose UDI-DI: 04046964797972 Description: 130 IN. IV ADMIN SET W/ 9 IN. EXT SET Sold worldwide including US, Canada, Germany, Guatemala, Singapore Quantity: 45,288 units Distribution: Worldwide distribution to US and international sites Expiration: Earliest Expiration of Component or up to 36 months Manufacturer: B. Braun Medical
No injuries or incidents have been reported.
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