B. Braun Medical recalled 19,392 Anesthesia IV Sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The devices present a risk of backflow of medication from secondary piggyback IV containers into the primary IV line and an inability to prime. Hospitals and providers should stop using the devices 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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The Anesthesia IV Set is used with gravity and pump-based IV administration in hospital settings, including compatibility with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
A backflow risk could lead to improper dosing or contamination of the primary IV line. An occlusion may prevent proper priming of the line, delaying or stopping medication delivery.
This recall is not described as part of a broader industry pattern.
Hospitals may need to halt use of affected sets, switch to alternate IV sets, and coordinate patient care to avoid dosing errors.
Labels on the device and packaging; recall notice page from FDA/recall URL
Not specified in the notice. Monitor the official recall page for updates.
Keep the recall notice, device labels, and all correspondence; photograph labels and store documentation for audit
Catalog Number: 490452; Primary UDI-DI: 04046964848933; Unit of Dose UDI-DI: 04046964848926; Quantity: 19,392 units; Distribution: Worldwide distribution with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
No injuries or incidents have been reported.
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