B Braun Medical recalled 129,480 IV administration sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers into primary containers. Patients and healthcare providers must stop using the devices immediately.
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 recalled IV administration sets include the following catalog numbers: 490242, 490311, and 490353. The products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The recall stems from a potential risk for backflow of medication from secondary IV containers into primary IV containers, which could lead to improper medication delivery. This defect can also prevent the devices from priming properly, creating occlusions.
No specific incidents reported. The recall is categorized as Class II, indicating a potential for serious injury or illness.
Patients and healthcare providers should immediately stop using these IV administration sets. Follow the recall instructions provided by the manufacturer and contact B Braun Medical Inc or your healthcare provider for further guidance.
For more information, contact B Braun Medical Inc. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0659-2026.
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