B. Braun Medical recalled 48 IV Administration Sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The devices carry a backflow and occlusion risk between secondary and primary IV containers. Healthcare providers and patients should stop using immediately and follow recall instructions. A recall letter will provide further guidance on returning or replacing the 제품
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 intravenous medications through gravity or pump systems. They connect to IV bags or bags and have Y-sites for secondary administration. They are used in hospital, clinic, and sometimes homecare settings.
Backflow from secondary to primary IV containers can result in incorrect dosing or contamination. Inability to prime may delay therapy and require additional clinical intervention.
This recall is not described as part of a broader industry pattern in the notice.
The recall could disrupt IV therapy delivery and require immediate replacement with safe equipment, potentially increasing clinical workload and costs.
Recall details and guidance are available via the FDA enforcement page and the manufacturer’s website.
Refunds or replacements typically take 4-8 weeks after confirmation and return of affected parts.
Keep the recall letter, take photos of product labels and UDIs, document dates of purchase and usage, save all correspondence with the manufacturer
Catalog Number: 490653; Primary UDI-DI: 04046955836338; Unit of Dose UDI-DI: 04046955836345; Sold worldwide including US, Canada, Germany, Guatemala, Singapore; Quantity: 48 units; Model variants labeled with catalog number 490653; Labeled as IV ADMIN 15D, 2 B/C VLV, CARESITE LADS
No injuries or incidents have been reported.
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