B. Braun Medical recalled 187,464 IV administration sets worldwide, including US distribution and shipments to Canada, Germany, Guatemala, and Singapore. The devices pose a backflow risk from secondary (piggyback) IV containers into primary containers and can fail to prime properly. Healthcare providers and patients should stop using the devices 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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IV administration sets deliver fluids via gravity or infusion pumps. The three catalog numbers differ in length and labeling.
Backflow from secondary to primary containers and occlusion can lead to incorrect dosing or contamination of IV fluids.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to replace affected sets; potential for dosing errors if backflow occurs; no injuries reported yet.
Refer to the labeling on the device and packaging. FDA recall page lists catalog numbers and UDIs.
4-8 weeks for refunds or replacements, depending on supplier and facility processes.
Save the recall notification, take photos of the product label, keep all correspondence with manufacturer and supplier.
Catalog Number 490488 — 126 in; IV Admin Set W/15 DROPS/ML. Catalog Number 490492 — 132 in; IV Admin Set W/15 DROPS/ML. Catalog Number 490503 — 139 in; IV Admin Set W/15 DROPS/ML. Primary UDI-DI for 490488: 04046955086870; Unit of Dose UDI-DI: 04046955086863. Primary UDI-DI for 490492: 04046955086757; Unit of Dose UDI-DI: 04046955086740. Primary UDI-DI for 490503: 04046955135714; Unit of Dose UDI-DI: 04046955135707. Expiration: Earliest Exp of Component or 24 months (490488); Earliest Exp of Component or 36 months (490492, 490503).
No injuries or incidents have been reported.
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