B Braun Medical recalls 19,104 IV Administration Sets distributed worldwide, including the United States and international distribution to Canada, Germany, Guatemala, and Singapore. The recall cites backflow of medication from secondary piggyback IV containers into primary IV lines and an inability to prime due to occlusion. The affected catalog number is 490400. Stop using the device and follow a
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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This IV administration set is used in hospitals to deliver medications and fluids. It supports both gravity-driven and pump-assisted infusion with secondary (piggyback) containers.
Backflow from secondary to primary IV lines can alter delivery of medications. Occlusion can prevent priming, delaying or altering intended dosing.
This recall is not described as part of a broader industry pattern in the provided information.
Hospitals may need to halt uses of affected sets, replace stock, and review infusion protocols to prevent dosing errors.
Identifiers are printed on the device label and packaging. The recall notice provides catalog and UDI details.
Refund or replacement processing may take 4-8 weeks after submission of a claim.
Keep the recall notice, purchase records, serial/UDI data, and all correspondence with the manufacturer.
Catalog Number: 490400; Primary UDI-DI: 04046964761393; Unit of Dose UDI-DI: 04046964761386; Where sold: Worldwide distribution; US distribution and international distribution to Canada, Germany, Guatemala, and Singapore; When sold: Unknown; Price: Unknown
No injuries or incidents have been reported.
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