B. Braun Medical recalls 25,728 IV administration sets sold worldwide, including the United States and Canada. The quad manifold 120-inch IV set may allow backflow from piggyback containers into primary containers and cannot be primed. Healthcare providers should stop using immediately and follow 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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The IV Administration Set Quad Manifold is used for gravity IV administration and pump-based IV delivery in clinical settings.
Backflow from secondary to primary IV containers can lead to incorrect dosing or contamination. Inability to prime can disrupt fluid delivery and patient safety.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to substitute IV sets quickly to avoid interrupted therapy. No injuries are reported in the data provided, but the risk to patient safety is material.
Recall notice and FDA enforcement page linked in the recall data: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0689-2026
Refund or replacement typically 4-8 weeks after submission of required information.
Keep the recall notice, photos of the device labeling, purchase records, and correspondence with the manufacturer.
Catalog Number: 490340 Primary UDI-DI: 04046964590481 Unit of Dose UDI-DI: 04046964590474 Description: IV ADMIN SET, QUAD MANIFOLD, 120 IN Sold: Worldwide distribution including US, Canada, Germany, Guatemala, Singapore Quantity: 25,728 units Recall Date: 2025-10-29 Status: Active Brand: B. Braun Medical
No injuries or incidents have been reported.
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