B Braun Medical recalled its IV Administration Set used with Infusomat Space Large Volume Pumps and related models. The recall cites backflow of medication from secondary to primary IV containers and an occlusion that prevents priming. Hospitals and clinicians should stop using the device immediately and follow manufacturer 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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This IV administration set delivers fluids and medications in hospital and clinical settings and is designed for use with infusion pumps and gravity administration.
Backflow into the primary IV line and occlusion of the line can cause incorrect dosing, delayed therapy, or contamination of medications.
This recall is not identified as part of a broader industry safety pattern in the provided information.
Hospitals must remove affected sets from use and obtain safe replacements to prevent dosing errors and potential patient harm.
Labeling on the IV set and accompanying packaging; FDA recall page for Z-0718-2026 details.
Recalls in hospital supply chains typically take 4-8 weeks for full remediation and replacement stock.
Document recall notice, supplier communications, inventory affected, and actions taken to remove and replace devices
Catalog Number: 490566. Primary UDI-DI: 04046955275625. Unit of Dose UDI-DI: 04046955275618. Expiration: Earliest Exp of Component or 36 months. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
No injuries or incidents have been reported.
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