B Braun Medical recalled 122,232 IV administration sets on October 29, 2025. The recall addresses potential backflow of medication from secondary IV containers into primary containers. Affected units were distributed worldwide including the US, Canada, Germany, Guatemala, and Singapore.
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 labeled as IV ADMIN SET, 129 IN, 3 CARESITE LADS; Catalog Number: 490225. The product has a Primary UDI-DI of 04046964304248 and a Unit of Dose UDI-DI of 04046964304231. The earliest expiration date is 36 months from manufacture.
The recall stems from a risk of backflow of medication from secondary IV containers into primary IV containers, which can lead to medication errors. This defect can also cause an inability to prime the device, leading to occlusion.
There have been no specific injury or incident counts reported related to this recall. The potential risks are classified as serious due to the high hazard level.
Patients and healthcare providers should stop using the recalled IV administration sets immediately. Follow the manufacturer’s instructions for return and contact B Braun Medical Inc or your healthcare provider for further guidance.
For more information, contact B Braun Medical Inc at [insert phone number] or visit their website at [insert website].
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