B Braun Medical recalled 46,250 IV administration sets on October 29, 2025. The recall follows concerns about potential backflow of medication into primary IV containers. The affected products were sold worldwide, including the US and Canada.
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 several models: UNIVERSAL IV ADMIN SET (Catalog Number: 352604), SAFELINE ADDITIVE (Catalog Number: NF1251), and SAFELINE PED. ADDITIVE (Catalog Number: NF1290). These sets were distributed internationally, including in the US, Canada, Germany, Guatemala, and Singapore.
The recalled IV sets pose a high risk due to potential backflow of medication from secondary IV containers. This could lead to unintended drug administration and patient safety concerns.
There have been no specific incidents reported related to this recall. However, the nature of the hazard raises serious concerns about patient safety.
Healthcare providers and patients should stop using the affected IV sets immediately. Contact B Braun Medical for instructions on the recall process.
For more information, call B Braun Medical at 1-800-xxx-xxxx or visit their website at www.braun.com.
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