B Braun Medical recalled 135,000 IV administration sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump, sold worldwide to hospitals and other healthcare providers. The devices pose a backflow risk from secondary to primary IV containers and can fail to prime. Health care facilities should stop using the affected sets and follow the manufacturer’s recall guidance.
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 administer fluids and medications either by gravity or pump systems in clinical settings. They connect to IV bags or containers and feed into patients through IV catheters.
Backflow can contaminate primary IV lines or doses, while occlusion can prevent proper priming and delivery of medications.
This recall is not described as part of a broader industry pattern in the provided data.
The recall affects hospitals and health systems worldwide. It requires immediate action to prevent potential medication administration errors and ensure patient safety.
FDA enforcement page for Z-0651-2026 and the BBraun Medical recall notice.
Refunds or replacements typically take 4-8 weeks after verification of affected inventory.
Keep the recall letter, purchase records, inventory lists, photographs of labeling (catalog and UDIs), and copies of all communications.
Catalog Number: 457515 Distribution: Worldwide distribution, including US and international markets (Canada, Germany, Guatemala, Singapore) Sold since: Unknown Price: Unknown Primary UDI-DI: 04046964716188 Unit of Dose UDI-DI: 04046964716171
No injuries or incidents have been reported.
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