B Braun Medical Inc. recalled 41,016 IV administration sets sold worldwide, including the United States, Canada, Germany, Guatemala and Singapore. The devices pose a risk of backflow from secondary piggyback IV containers into primary containers and may fail to prime. Healthcare providers and patients should stop using the device immediately and follow recall instructions sent by letter.
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 connect IV fluids to a patient. They can be used with gravity or pump systems such as BBraun Infusomat Space, Outlook Pump, and Vista Basic Pump.
The defect allows backflow of medication from secondary containers into the primary line and may prevent proper priming, risking dose errors or contamination.
This recall is not part of a broader industry pattern.
41,016 units recalled; high-risk device. Immediate action required to prevent potential medication backflow or occlusion.
Label on packaging and accompanying recall letter.
Remedy steps and replacement information will be provided by the manufacturer; processing times vary by facility.
Retain recall letter, take photographs of packaging and labels, save UDIs and catalog numbers, log communications with the manufacturer.
Catalog numbers: 490522 and 490568. Primary UDI-DI: 04046955203123; Unit of Dose UDI-DI: 04046955203116; Expiration: earliest expiration of component or 36 months. Catalog number: 490568; Primary UDI-DI: 04046955275663; Unit of Dose UDI-DI: 04046955275656; Expiration: earliest expiration of component or 36 months. Sold worldwide, including US, Canada, Germany, Guatemala, and Singapore.
No injuries or incidents have been reported.
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