B Braun Medical recalled 10,896 IV administration sets on October 29, 2025. The recall addresses a risk of medication backflow from secondary IV containers. This issue could lead to serious health risks for patients.
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 model labeled as IV ADMIN SET W/CARESITE EXT SET; Catalog Number: 490407. These products have a Primary UDI-DI of 04046964773242 and a Unit of Dose UDI-DI of 04046964773235. The affected devices were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The recall stems from a potential backflow of medication from secondary IV containers into primary IV containers. Additionally, there is an inability to prime due to occlusion, which poses a high risk to patient safety.
While specific incident counts were not reported, the hazard presents a high risk of serious health complications. Improper medication delivery can result in adverse health effects for patients receiving intravenous therapy.
Patients and healthcare providers must stop using the recalled IV administration sets immediately. Follow the manufacturer's recall instructions and contact B Braun Medical Inc or your healthcare provider for further guidance.
For more information, contact B Braun Medical Inc at 1-800-xxx-xxxx or visit their website. Additional details are also available on the FDA recall page.
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