B Braun Medical recalled 24,624 Blood Administration Sets worldwide. The recall covers sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The risk involves backflow from secondary IV containers into primary containers and the inability to prime. Hospitals and clinics should stop using the devices 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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Blood administration sets are used to deliver blood products or IV medications via gravity or pump systems. They connect to IV bags or bottles and routes to the patient through tubing and a Y-site. These sets are used in hospitals and clinics.
Backflow can cause unintended administration of medications and compromised priming, risking incorrect dosing or contamination.
This recall is not stated as part of a broader industry pattern in the provided data.
Hospitals may need to quarantine affected inventory and switch to replacement sets, impacting workflow and potentially delaying treatments.
Recall notice and instructions available at the FDA enforcement page linked in the recall notice.
Replacement or refund processing times will be provided by the manufacturer; typical timelines vary by facility.
Keep the recall notice, catalog number, UDIs, purchase records, and all correspondence with the manufacturer for records.
Catalog Number: 490355. Distribution: Worldwide, including United States, Canada, Germany, Guatemala, and Singapore. Sold since: Unknown. Price: Unknown. Primary UDI-DI: 04046964616013. Unit of Dose UDI-DI: 04046964616006.
No injuries or incidents have been reported.
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