BBraun Medical Inc recalls 960 IV administration sets distributed worldwide due to backflow risk and inability to prime. The recall affects the IV administration set catalog number 490491 with UDI-DI 04046955086931. The device can allow medication to flow from secondary piggyback containers into primary IV containers and may not prime properly. Stop using 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 IV administration set is used to deliver medications via gravity or through IV pumps in healthcare settings.
Backflow from secondary to primary IV containers can alter dosing. Inability to prime can cause incomplete administration.
This recall is not described as part of a broader industry pattern in the provided data.
No injuries reported yet. Healthcare facilities will need to replace affected sets and monitor for potential dosing issues during IV administration.
UDI labels are typically printed on packaging and the device itself. Refer to FDA recall page for official identifiers.
Manufacturer-led remediation will determine replacement or refunds; expect 4-8 weeks for processing after request.
Keep recall notification, purchase records, Photos of the device, serials/UDI, and correspondence with manufacturer.
Product: IV Administration Set used in gravity and pump administration with BBraun Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Catalog Number: 490491. Primary UDI-DI: 04046955086931. Unit of Dose UDI-DI: 04046955086924. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 960 units. Hazard: backflow from secondary (piggyback) containers into primary containers and inability to prime.
No injuries or incidents have been reported in the provided data.
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