B. Braun Medical recalled 381,850 CareSite IV sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump after concerns about backflow and occlusion. The defect could allow medication to flow from secondary piggyback IV containers into primary IV containers and prevent priming. Hospitals and clinicians should stop using the affected devices immediately and follow recall,厂
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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CareSite injection sites are used in gravity IV sets and pump administration sets for IV therapy. They connect to IV lines and are used in hospital settings with infusion pumps.
The defect allows backflow from secondary IV containers into the primary IV container and may prevent priming, potentially affecting dosing accuracy.
This recall is not described as part of a broader industry pattern.
Hospitals may need to halt use of affected IV sets and implement replacements. A recall of 381,850 units implies substantial procurement and workflow impact.
Recall details and instructions are available on the FDA enforcement page linked in the recall notice.
Refund or replacement processing typically takes 4-6 weeks after a claim is submitted.
Document recall notice, catalog number, and UDI numbers. Save correspondence with the supplier and any replacement orders.
Catalog Number: 354207. Primary UDI-DI: 04046964182136. Unit of Dose UDI-DI: 04046964182129. Distribution: Worldwide, including US, Canada, Germany, Guatemala and Singapore. Sold by B. Braun Medical. Price: Unknown.
No injuries or incidents have been reported.
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