B Braun Medical Inc recalled 2,544 IV administration sets due to risk of backflow from secondary piggyback containers into primary IV lines and inability to prime. The recall covers products used with BBMI Infusomat Space, Outlook, and Vista Basic pumps and distributed worldwide including the US, Canada, Germany, Guatemala and Singapore. Patients should stop using the device immediately and follow
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 deliver medications through IV lines. They connect to IV bags or reservoirs and to patient IV catheters. A recall indicates a risk of backflow and occlusion affecting drug delivery.
Backflow from secondary to primary IV lines can result in improper dosing. Occlusion prevents proper priming and flow.
This recall does not indicate a broader industry pattern in this document.
Immediate halt of use is required to prevent potential medication delivery errors and patient harm.
UDI on packaging and device labeling; recall notice and FDA enforcement page
Remedies provided by the manufacturer; replacement or refund timelines vary by institution
Keep recall notice, photos of catalog and UDIs, purchase receipts, and correspondence with supplier
Model numbers and details: Catalog Number 490451. Primary UDI-DI 04046964848919. Unit of Dose UDI-DI 04046964848902. Expiration date: Earliest expiration of component or 36 months. Quantity: 2,544 units. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore.
No injuries or incidents information is provided in the memo. The status is ACTIVE with hazard level HIGH.
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