B. Braun Medical recalled 7,344 Blood Administration Sets used with Infusomat Space, Outlook Pump, and Vista Basic Pump. The devices may allow backflow from secondary (piggyback) IV containers into primary IV containers and cannot be primed. Hospitals and healthcare providers should stop using the devices immediately and follow manufacturer 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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Blood administration sets are used to deliver blood products via gravity or pumped IV systems. They connect to IV bags or containers and are used in hospital settings for transfusions.
A backflow risk means medication could flow backwards from a secondary container into the primary line, potentially altering dosage. An occlusion can prevent proper priming and flow.
This recall is not described as part of a broader industry pattern in the provided data.
The recall could disrupt transfusion workflows and delay treatment in hospitals if affected sets remain in use.
Recall notices and instructions are available on the FDA enforcement page linked in the notice
Processing times for replacement or remedy are not specified; hospitals should coordinate with BBraun Medical and suppliers
Keep copy of the recall notice, model numbers, UDIs, purchase records, and all communications with the manufacturer and suppliers
Catalog Number: 490196. Primary UDI-DI: 04046964303722. Unit of Dose UDI-DI: 04046964303715. Sold worldwide, including US, Canada, Germany, Guatemala, and Singapore. Product description: Y-TYPE BLOOD SET 124 IN. Distribution: Worldwide distribution.
No injuries or incidents have been reported.
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