B Braun Medical recalled 1,200 extension sets used with Infusomat Space large-volume pumps distributed worldwide to hospitals and clinics. The recall cites potential backflow from secondary IV containers into primary containers and an inability to prime (occlusion). Healthcare facilities should stop using the devices immediately and follow the recall instructions issued by 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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The extension set is used with gravity IV administration and pump systems to deliver medications and fluids. It connects medication containers to patients via IV lines.
Backflow from secondary (piggyback) IV containers into primary IV containers can occur with these sets. The assembly may also fail to prime, leading to incorrect medication delivery.
This recall is not described as part of a broader industry pattern in the provided documentation.
Hospitals and clinics using these sets risk improper dosing. The recall affects 1,200 units distributed worldwide, creating potential patient safety and workflow disruptions.
UDI-DI numbers and Catalog Number appear on the product label and packaging. The recall page lists 490358 as the catalog reference and the two UDIs as identifiers.
The notice does not specify a remediation timeline.
Keep the recall notice, purchase orders, batch records, and correspondence with the manufacturer. Photograph affected items and document quantities in stock.
Catalog Number: 490358. Primary UDI-DI: 04046964642746. Unit of Dose UDI-DI: 04046964642739. Quantity: 1,200 units. Sold worldwide to hospitals and clinics, including US and international distribution to Canada, Germany, Guatemala, and Singapore.
No injuries or incidents have been reported.
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