B. Braun Medical Inc. recalls 300 extension sets used with Infusomat Space and other pumps. The recall flags potential backflow from piggyback IV containers into primary IV containers and the inability to prime. Hospitals should stop using the device immediately and follow 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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This extension set is used to connect IV piggybacks or secondary bags to primary IV lines in hospital settings.
Backflow could move medication from secondary to primary lines and occlusion could prevent proper flushing and dosing.
This recall is not part of a broader industry pattern.
Hospitals must verify catalog numbers and stop using affected lots to prevent dosing errors.
Manufacturer recall notice and FDA enforcement page.
Refunds or replacements timelines will be determined by the manufacturer; no specific window provided here.
Keep recall letter, inventory lists, and correspondence with the manufacturer
Model numbers and identifiers: Catalog Number V5405. Primary UDI-DI 04046964188978. Unit of Dose UDI-DI 04046964188961. Quantity: 300 units. Distribution: Worldwide with US, Canada, Germany, Guatemala, Singapore.
No specific injuries or incidents are mentioned in the provided data. The status is ACTIVE with a HIGH hazard level.
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