B. Braun Medical Inc. recalled 12,225,913 CARESITE gravity IV sets and pump sets used with Infusomat Space, Outlook Pump, and Vista Basic Pump. The devices may backflow medication from secondary to primary IV containers and fail to prime. Healthcare facilities and patients should stop using immediately and follow the recall instructions from the manufacturer. For refund or replacement inquiries,联系
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-enabled IV sets are used for gravity and pump-administered IV therapies. They are used in clinical settings to deliver medications intravenously with various pumps.
Backflow from secondary IV containers into primary containers and failure to prime can lead to dosing errors or contamination of IV lines.
This recall is not described as part of a broader industry pattern.
The recall aims to prevent medication backflow and occlusion issues that could affect patient safety and treatment efficacy in hospital settings.
Recall notice and device labeling contain UPC/UDI identifiers and catalog numbers.
Replacement or corrective action timelines typically align with manufacturer instructions and regulatory guidance; expect updates from BBraun Medical.
Keep copy of recall notice, take photos of product labels, retain purchase receipts if applicable, log all communications with the manufacturer and regulatory bodies.
Catalog Numbers: 354204, 354205, 354206 Primary UDI-DI: 04046964182075; Unit of Dose UDI-DI: 04046964182068 Catalog Numbers: 354205 Primary UDI-DI: 04046964182099; Unit of Dose UDI-DI: 04046964182082 Catalog Numbers: 354206 Primary UDI-DI: 04046964182112; Unit of Dose UDI-DI: 04046964182105 Distribution: Worldwide, including US and international distribution to Canada, Germany, Guatemala, and Singapore Sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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