B Braun Medical Inc. recalls 190,625 IV administration sets worldwide, including US and Canada, for risk of backflow from secondary to primary IV containers and occlusion that prevents priming. The recall affects BBMI’s Infusomat Space, Outlook Pump, and Vista Basic Pump compatible sets. Stop-use 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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IV administration sets deliver fluids via gravity or pump systems. They are essential in hospitals and clinics for controlled medication delivery.
Backflow can cause unintentional dosing or contamination of the primary line. Occlusion prevents proper priming and flow.
This recall is not part of a broader industry pattern.
High risk to patients if backflow occurs; impacts hospital workflows and patient safety.
UDI-DI on packaging and product labels; catalog numbers printed on tubing sets
Recall effectiveness will depend on provider replacements; refunds/replacements may take weeks to months
Retain recall notice, order numbers, and replacement documentation; photograph labels
Product: IV Administration Set. Catalog numbers: 490528, 490550, 490605, 490616, 490654. Distributed worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 190,625 units. Brands: B Braun Medical Inc. Models/UDIs aligned with catalog numbers and expirations listed below.
No injuries or incidents have been reported in the provided data.
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