B Braun Medical recalled 7,344 blood administration sets on October 29, 2025. The recall follows a potential backflow hazard that could affect patient safety. Healthcare providers must stop using the affected 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 recalled product is the Y-TYPE BLOOD SET with Catalog Number 490196. The units were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The blood administration sets may allow for backflow of medication from secondary IV containers into primary IV containers. This situation poses a significant risk of medication errors and patient safety concerns.
No specific incidents or injuries have been reported at this time. The classification of this recall is Class II, indicating a potential risk that requires attention.
Patients and healthcare providers should stop using the device immediately. Follow any instructions provided in the recall notification and contact B Braun Medical Inc or your healthcare provider for further guidance.
For more information, contact B Braun Medical at their customer service line or visit their website. Additional details can also be found on the FDA's recall page.
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