B Braun Medical issued a recall for 1,250 IV administration sets on October 29, 2025. The recall stems from a potential backflow of medication between IV containers, posing a serious risk to patients. Healthcare providers and patients 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 recall affects the ULTRASITE IV ADMIN SET 60DROP with Catalog Number 352394. The product has been distributed globally, including the US, Canada, Germany, Guatemala, and Singapore.
The IV administration sets may allow medication to backflow from secondary IV containers into primary containers. This backflow can lead to patient harm due to unintended medication dosage.
There have been no specific injury reports associated with this recall. The potential for harm remains significant due to the nature of IV medications.
Patients and healthcare providers should immediately stop using the recalled IV administration sets. Contact B Braun Medical Inc or your healthcare provider for further instructions regarding the recall.
For more information, visit [B Braun Medical's recall page](https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0644-2026).
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