B Braun Medical recalled 162,648 Outlook IV Sets used with Infusomat Space Large Volume Pumps and related systems. The devices carry a backflow risk from secondary piggyback IV containers into primary IV containers and may fail to prime. Hospitals and patients 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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The Outlook IV Set is an infusion line used to deliver IV medications. It is compatible with various BBMI pump systems and is labeled for use in hospital and clinical settings.
A backflow path can transfer medication from a secondary IV container into the primary line. Occlusion can prevent proper priming of the line, potentially compromising delivery and patient safety.
This recall is not described as part of a broader industry pattern.
Healthcare facilities may need to remove the affected sets from inventory and switch to alternatives. The recall reduces the risk of unintended medication backflow and priming failure, but requires action from providers to re-source safe IV sets.
Identifiers are located on the device packaging and accompanying documentation. The FDA recall page provides official instructions.
Refunds or replacements are not specified in the recall; facilities should expect guidance to come from B Braun Medical with any replacement timing to
Keep a copy of the recall notice, record correspondence with the manufacturer, and save replacement product details.
Model numbers: Catalog Number 354212. Where sold: Worldwide distribution including US, Canada, Germany, Guatemala, Singapore. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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