B Braun Medical recalls 61,423 extension sets used with Infusomat Space, Outlook, and Vista pumps. The recall cites a potential backflow from secondary to primary IV lines and an inability to prime. Stop using the device immediately and follow recall instructions from the manufacturer.
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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This extension set is used to connect IV medication containers to a patient via gravity or electronic infusion pumps. It is common in hospital settings for delivering continuous medications.
Backflow from secondary IV containers into primary lines could cause incorrect dosing or contamination. Inability to prime increases infusion risk.
This recall is not described as part of a broader industry pattern in the provided data.
Healthcare facilities may need to halt use while replacements are sourced, potentially affecting workflow and medication administration.
Manufacturer recall communications and FDA enforcement page Z-0637-2026.
Facilities should expect shipments of replacement or remediation guidance within weeks to a few months depending on supply chain.
Retain recall notice, communications with supplier, purchase records, and photos of affected units and UDIs.
Extension Set for gravity IV administration and pump administration used with BBraun Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump. Catalog numbers 456521 and 456522. Primary UDI-DI 04046964296710 and 04046964296734 for the two catalogs. Unit of dose UDI-DI 04046964296703 and 04046964296727. 61,423 units distributed worldwide, including US, Canada, Germany, Guatemala, and Singapore. Recall Date: 2025-10-29. Status: ACTIVE.
No incidents or injuries are detailed in the provided recall information. No other incident counts are listed.
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