B Braun Medical recalled 4,488 IV administration sets distributed worldwide, including the United States, Canada, Germany, Guatemala and Singapore. The devices risk backflow from secondary (piggyback) IV containers into primary containers and may be unable to prime due to occlusion. Healthcare facilities and patients should stop using immediately and follow recall instructions from the maker.
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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IV administration sets connect IV bags or bottles to patients and include tubing and a pump-compatible interface. This product is used in gravity and pump-assisted administration.
Backflow can send medication from a piggyback line into the primary line, and occlusion can prevent proper priming of the line, potentially delivering an incorrect dose or compromising sterility.
This recall is not part of a broader industry pattern.
Hospitals and clinics using these sets may face supply interruptions and protocol changes. The recall emphasizes patient safety and proper line priming.
UDI codes and catalog numbers are printed on the device and packaging.
Recall processing and replacements may take 4-8 weeks once initiated.
Retain recall letter, take photos of the product and labels, save correspondence with the manufacturer.
Catalog Number: 490551 Length: 127 inches Description: IV Administration Set for gravity IV administration and pump systems with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump Global distribution: US, Canada, Germany, Guatemala, Singapore Expiration: Earliest Exp of Comp or 36 months Recall date: 2025-10-29 Status: ACTIVE UDI references: Primary UDI-DI 04046955275304; Unit of Dose UDI-DI 04046955275298
No injuries or incidents have been reported.
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