B. Braun Medical recalled 10,536 Anesthesia IV Sets sold through multiple retailers worldwide after a potential backflow from piggyback to primary IV lines and occlusion. The devices are used with Infusomat Space Large Volume Pumps, Outlook Pumps, and Vista Basic Pumps. Hospitals and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
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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Anesthesia IV Sets are used to deliver anesthesia agents through gravity or pump systems in hospital settings.
Backflow into the primary IV line and occlusion can disrupt correct dosing and patient safety during administration.
This recall is not described as part of a broader industry-wide pattern in the provided data.
Hospitals may need to halt use of affected sets and source safe replacements, potentially affecting procedures and scheduling.
Recall notice and FDA enforcement page linked in official communications.
Refunds or replacements typically follow 4-6 weeks after verification of affected inventory.
Keep copies of recall notices, distribution lists, and correspondence with supplier for records.
Catalog Number: 490472; Primary UDI-DI: 04046964958878; Unit of Dose UDI-DI: 04046964958861. Distribution: Worldwide; US distribution and distribution to Canada, Germany, Guatemala, and Singapore. Sold through hospitals and healthcare distributors. Price: Unknown.
No injuries or incidents have been reported.
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