B Braun Medical recalled 554,015 IV administration sets on October 29, 2025. The recall addresses a high risk of medication backflow into primary IV containers. Patients and healthcare providers must stop using these sets 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 recall involves SafeDAY sets used in gravity IV administration sets and pump administration sets with catalog number 352646. These products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The IV administration sets pose a high risk of backflow of medication from secondary IV containers into primary containers. This defect can lead to incorrect dosages and serious health risks.
No specific incidents or injuries have been reported as of now. The potential for serious harm remains due to the nature of the backflow hazard.
Stop using the affected IV administration sets immediately. Follow the recall instructions provided by B Braun Medical Inc. Contact your healthcare provider for further guidance.
For more information, call B Braun Medical Inc. or visit their website. The recall notification method includes a letter to users.
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