B. Braun Medical Inc. recalls 1,080 IV Administration Sets used with Infusomat Space, Outlook, and Vista Basic pumps. The recall addresses backflow from secondary piggyback containers into primary IV containers and an inability to prime (occlusion). Health care providers and patients should stop using the devices immediately and follow the manufacturer’s 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 in clinical settings to deliver fluids and medications through IV lines. They can be connected to secondary piggyback containers or primary IV lines.
Backflow can contaminate or alter medication delivery. An occlusion can prevent accurate priming, affecting dose delivery and flow.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to halt use of affected sets, which could disrupt patient care and require reallocation of supplies.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0672-2026
Not specified in recall notice. Follow manufacturer instructions for replacement or remediation.
Keep a copy of the recall notice, record all communications with the manufacturer, and preserve affected product packaging for audit.
Model numbers and identifiers: Catalog Number 490519; Primary UDI-DI 04046955185238; Unit of Dose UDI-DI 04046955186549. Expiration: earliest expiration of component or 36 months. Sold worldwide, including US, Canada, Germany, Guatemala, and Singapore. Quantity: 1,080 units. Distribution: Worldwide distribution.
No injuries or incidents have been reported.
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