B Braun Medical recalled over 12 million IV administration sets on October 29, 2025. The recall affects models sold worldwide, including the U.S., due to a potential backflow risk of medication. Users should stop using these devices immediately and follow manufacturer instructions.
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 includes the following models: Catalog Number 354204, 354205, and 354206. These products were sold worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore. The quantity recalled is 12,225,913 units.
The IV administration sets may allow backflow of medication from secondary IV containers into primary containers, leading to potential medication contamination. This could compromise patient safety and treatment efficacy.
As of now, there have been no reported injuries or deaths related to this issue. The recall stems from a concern about the device's ability to function properly in a clinical setting.
Stop using the recalled IV administration sets immediately. Follow the recall instructions provided by B Braun Medical Inc. Patients and healthcare providers should contact B Braun or their healthcare provider for guidance.
For more information, contact B Braun Medical at 1-800-328-8023 or visit their website at www.bbraun.com.
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