B. Braun Medical recalled 4,536 IV administration sets globally after reports of backflow risk and occlusion. The sets labeled catalog 490437 are used with gravity IV administration and pump systems such as Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Patients and healthcare providers should stop using the devices immediately and follow the 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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IV administration sets deliver fluids and medications from bags or bottles to patients via IV lines. This recall concerns sets compatible with gravity and pump-driven administration.
Backflow from secondary piggyback containers into primary IV lines can lead to improper dosing or contamination risk. Occlusion can prevent proper priming of the line, potentially interrupting fluid delivery.
This recall is not described as part of a broader industry pattern in the provided data.
The hazard is serious for patient safety. Healthcare facilities may need to quarantine affected inventory and implement interim controls to prevent continued use.
UDI-DI codes and catalog numbers are typically on the IV set package and on the product labeling.
Refund or replacement processing can take 4-8 weeks after submission, depending on supplier and location.
Keep recall notice, purchase receipts, product photos, and all correspondence. Document dates of contact and responses.
Catalog Number: 490437 Description: IV ADMIN SET W/ 15 DROPS/ML, 118 IN. Primary UDI-DI: 04046964833427 Unit of Dose UDI-DI: 04046964833410 Expiration Date: Earliest Exp of Comp or 24mths Sold/distributed: Worldwide distribution — US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Quantity recalled: 4,536 units Recall date: 2025-10-29 Manufacturer: B. Braun Medical (BBraun Medical)
No injuries or incidents have been reported.
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