B. Braun Medical Inc. recalls 40,992 IV administration sets used with Infusomat Space, Outlook, and Vista Basic pumps sold to hospitals worldwide. The recall targets the IV administration set catalog number 490245. The defect is backflow of medication from secondary piggyback containers into primary containers and an inability to prime. Healthcare providers and patients should stop using theDevice
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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IV administration sets connect IV bags or piggyback containers to patients. They are used with gravity feeds or infusion pumps. The labeled catalog 490245 specifies 15 drops per milliliter and 133 inches of tubing.
A backflow scenario occurs when medication from a piggyback container re-enters the primary IV line. An occlusion may prevent priming, hindering proper administration of IV fluids or medications.
This recall is not indicated as part of a broader industry pattern.
Hospitals may need to halt use of affected sets, replace stock, and re-train staff on device selection and infusion procedures.
Refer to the FDA recall page Z-0676-2026 and manufacturer recall communications for instructions and replacement options.
The recall notice does not specify a replacement or refund timeline.
Keep the recall letter, packaging, UDIs, and purchase records. Save all correspondence with the manufacturer. Photograph affected labeling for records.
Catalog Number: 490245; Label: IV ADMIN SET W/15 DROPS/ML, 133 IN.; Primary UDI-DI: 04046964716508; Unit of Dose UDI-DI: 04046964716492; Distribution: Worldwide; US distribution and international to Canada, Germany, Guatemala, Singapore; Sold since: Unknown; Price: Unknown
No injuries or incidents have been reported.
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