B Braun Medical recalled 65,904 IV administration sets on October 29, 2025, due to a risk of backflow from secondary IV containers. This could lead to medication errors that may endanger patients. The sets are used with several pumps, including the Infusomat Space and Outlook Pump.
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 product is the IV Administration Set, catalog number 490283. It is utilized in both gravity and pump administration systems. These sets were distributed worldwide, including in the US, Canada, Germany, Guatemala, and Singapore.
There is a potential for backflow of medication from secondary IV containers into primary IV containers. This defect may cause medication errors and could compromise patient safety.
No specific incidents or injuries were reported at this time. The recall was issued as a precautionary measure based on potential risks.
Patients and healthcare providers must stop using the recalled IV administration sets immediately. They should contact B Braun Medical Inc or their healthcare provider for further instructions regarding the recall.
For more information, contact B Braun Medical Inc or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0656-2026.
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