B. Braun Medical recalled 3,120 IV administration sets distributed worldwide to hospitals and clinics. The recall concerns potential backflow of medication from secondary piggyback containers into primary containers and an inability to prime. Hospitals and clinicians should stop using the devices immediately and follow the recall instructions issued by the manufacturer.
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 medication through IV lines in hospitals and clinics. They come in gravity and pump configurations and connect to infusion pumps such as Infusomat Space, Outlook, and Vista Basic.
Backflow from secondary piggyback IV containers into primary IV containers can alter dosing. Inability to prime can prevent proper fluid delivery.
This recall is not stated as part of a broader industry pattern.
The recall is high risk for patients who rely on precise IV dosing in clinical settings. No injuries reported yet.
Identifiers are on packaging labels and the device itself.
Refunds or replacements, if offered, typically take 4-8 weeks after processing.
Document recall notification, catalog numbers, UDIs, dates, and communications. Photograph labels.
Model numbers: Catalog Number 490489; Primary UDI-DI 04046955086894; Unit of Dose UDI-DI 04046955086887. Sold worldwide, including US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Sold since unknown. Price unknown.
No injuries or incidents have been reported.
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