B. Braun Medical recalls 7,008 IV administration sets sold worldwide, including the United States, Canada, Germany, Guatemala and Singapore. The devices may backflow from secondary to primary IV containers and may fail to prime. Hospitals and patients 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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IV administration sets are used to deliver medications and fluids through intravenous therapy. They connect to bags or containers and interfaces with pumps in clinical settings.
Backflow from secondary IV containers into primary lines can alter dosing. An occlusion can prevent priming and delivery of medications, risking under- or overdosing.
This recall is not identified as part of a broader industry pattern.
The recall affects hospital and patient safety for a critical treatment pathway. No reported injuries yet, but the risk could affect patient care and require replacement stock at facilities.
Recall notice and FDA enforcement page linked in the recall press release
Refunds or replacements typically processed within 4-8 weeks after verification
Keep the recall notice, product packaging, photos of labels, and all communications with the manufacturer for records
Catalog Number: 490542. Primary UDI-DI: 04046955270187. Unit of Dose UDI-DI: 04046955270170. Expiration: Earliest Exp of Component or 36 months. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore. Quantity: 7,008 units.
No injuries or incidents have been reported.
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