B. Braun Medical recalled 1,861,111 IV Administration Sets sold globally through hospitals and medical distributors. The sets may allow backflow from secondary to primary IV containers and cannot be primed. Hospitals and clinicians using these sets with Infusomat Space, Outlook, or Vista Basic Pumps should stop using them immediately and contact B. Braun Medical for 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 fluids and medications via gravity or pump-assisted IV therapy in clinical settings.
Backflow can transfer medication from a secondary line to the primary line and may prevent proper priming, risking incorrect dosing or contamination.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to halt use of affected units, which could impact patient care and supply chains.
Recall notice and official instructions are on the FDA recall page linked in the notice and on the manufacturer’s site.
Remedy processing and replacements typically occur within weeks to a couple of months, depending on stock and physician coordination.
Retain all recall notices, purchase records, and correspondence with the manufacturer or healthcare facilities for audit and insurance purposes.
Catalog Number 354210: IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks. Catalog Number 490389: IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN. Sold worldwide; US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 1,861,111 units. Recall Date: 2025-10-29; Report Date: 2025-12-03. Manufacturer: B. Braun Medical Inc. Remedy: Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun
No injuries or incidents have been reported.
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