B Braun Medical recalled 190,625 IV administration sets on October 29, 2025. The recall addresses a potential backflow of medication from secondary IV containers. Healthcare providers must stop using the device immediately to prevent serious complications.
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: 490528, 490550, 490605, 490616, and 490654. These products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. They were sold through multiple retailers.
The recall concerns the potential for backflow of medication from secondary IV containers into primary IV containers and the inability to prime due to occlusion. This situation poses a high risk to patient safety, as it can lead to incorrect medication delivery.
There are no reported injuries or incidents related to this recall at this time. However, the potential for serious complications exists if the device is used.
Stop using the recalled IV administration sets immediately. Follow the recall instructions provided by B Braun Medical Inc. Healthcare providers should contact B Braun Medical or their healthcare provider for further instructions.
For more information, contact B Braun Medical Inc at the number found on their website. You can also visit the recall notice on the FDA's website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0669-2026.
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