B. Braun Medical recalled 15,250 PB1500 15-DROP IV SETS distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore. The devices pose a backflow risk from secondary IV containers into primary containers and may fail to prime. Healthcare facilities should stop using the product and follow recall 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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IV administration sets are used to deliver medications via gravity or pump systems. This recall covers PB1500 15-DROP SETS used with Infusomat Space large-volume pumps, Outlook pumps, and Vista Basic pumps.
Backflow from secondary to primary IV containers and failure to prime could disrupt medication delivery and patient safety.
This recall is not described as part of a broader industry safety pattern in the provided data.
Hospitals and clinics may need to identify affected lots quickly, halt use, and coordinate with providers to source replacements, potentially affecting patient treatment workflows.
Recall notices are accessible via the FDA enforcement page linked in this article and through the manufacturer’s recall communications
Replacement or remediation may take 4-6 weeks in hospital settings
Keep the recall letter, serials/UDI data, purchase records, and all correspondence with the manufacturer and regulators.
Catalog Number: 490025 Primary UDI-DI: 04046964301056 Unit of Dose UDI-DI: 04046964301049 Expiration: Earliest Expiration of Component or 60 months Sold worldwide: Worldwide distribution including US, Canada, Germany, Guatemala, Singapore Quantity: 15,250 units Product: PB1500 15-DROP IV SET W/2 STOPCOCKS Hazard: Potential for backflow of medication into primary IV containers and inability to prime Recall Date: 2025-10-29 Status: ACTIVE
No injuries or incidents have been reported.
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