B Braun Medical Inc. recalls 111,312 IV Administration Sets worldwide, including US and international markets, due to backflow risk and occlusion. The recall affects catalog numbers 490193 and 490326, used with Infusomat Space, Outlook, and Vista Basic pumps. Stop using immediately and follow recall instructions for refunds or replacements.
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 through IV pumps or gravity systems. They connect to IV bags or bottles and to patient IV catheters.
Backflow could transfer medication from the piggyback line into the primary line, potentially altering dose delivery. An occlusion may prevent priming and secure flow.
This recall is not clearly part of a broader industry pattern in the provided data.
Health systems may need to replace affected sets and review IV administration protocols to prevent backflow and ensure reliable priming.
UDI codes are on product packaging and accompanying documentation.
Refunds or replacements typically process within 4-8 weeks after verification.
Document catalog numbers, UDI codes, dates, supplier communications, and any adverse events or near misses.
IV Administration Set products recalled by B Braun Medical Inc. include: Catalog Number 490193 with Primary UDI-DI 04046964303661 and Unit of Dose UDI-DI 04046964303654; Expiration: Earliest expiration of components or 24 months. Catalog Number 490326 with Primary UDI-DI 04046964541063 and Unit of Dose UDI-DI 04046964541056; Expiration: Earliest expiration of components or 24 months. These sets are labeled for use with gravity IV administration and pump administration with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Distributed worldwide, including US, Canada,
No specific injury counts are provided in the available data. The recall status is active with a high hazard level.
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