B Braun Medical Inc. recalls 28,344 IV administration sets used with several BBMI infusion pumps after reports of backflow and occlusion risks. The recall covers a catalog number 470179 device distributed worldwide including the U.S., Canada, Germany, Guatemala and Singapore. The issue involves potential backflow from secondary IV containers into primary containers and the inability to prime the管.
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 are used to deliver intravenous medications via gravity or pump systems. This recall targets sets used with BBMI infusion pumps including Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Backflow can cause medication to flow into the wrong container and occlusion can prevent proper priming, risking incorrect dosing or contamination.
This recall is not described as part of a broader pattern in the provided data.
Hospitals and clinics must halt use of affected sets; facilities may need to inspect inventory and replace with safe alternatives, potentially impacting patient care timelines.
Recall details at FDA enforcement page Z-0688-2026
Remediation timelines not specified; expect supplier coordination for replacement within weeks
Retain recall notice, document lot numbers, purchase dates, and correspondence with supplier
IV ADMIN SET W/ B/C VALVE, 103 IN. Catalog Number: 470179. Primary UDI-DI: 04046964773181. Unit UDI-DI: 04046964773174. Expiration: Earliest Exp of Component or 36 months. Sold worldwide, including US, Canada, Germany, Guatemala, Singapore.
No specific incident counts are provided in the filing. The recall is classified as HIGH hazard.
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