B Braun Medical recalled 13,600 IV administration sets on October 29, 2025. The recall affects models catalog number 490202 due to a potential backflow hazard. Healthcare providers and patients should 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 involves IV administration sets labeled as EXT SET W/ B/C VLV, ULTRAPORT, 57 IN.; Catalog Number: 490202. These were distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.
The recalled extension sets present a high hazard risk due to the potential backflow of medication from secondary IV containers into primary IV containers. Additionally, users may experience difficulty in priming the device, leading to occlusion.
As of the recall date, there are no reported injuries or deaths related to this issue. The nature of the hazard could lead to serious medication errors if not addressed.
Healthcare providers and patients should stop using the recalled IV administration sets immediately. They should follow the recall instructions provided by B Braun Medical Inc or their healthcare provider.
For more information, contact B Braun Medical Inc. at their customer service number or visit their website. Additional details can be found at the FDA recall page.
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