B. Braun Medical recalled 32,500 Caresite Extension Sets used with Infusomat Space, Outlook, and Vista Basic IV pumps worldwide. The devices pose a backflow and occlusion risk in the primary IV line. Hospitals and healthcare providers should stop using the device immediately and follow the 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 extension set is used to connect gravity IV therapy lines and pump-administered lines in hospital settings.
Backflow could cause incorrect dosing or contamination of the IV line. Inability to prime may interrupt medication delivery.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals must identify and remove affected extension sets from inventory to protect patient safety. Facilities should follow the manufacturer’s recall instructions to replace or remedy the device.
Recall notice and FDA enforcement page provide device identification and instructions.
Remedy details and replacement or refund timeline will be provided by the manufacturer in the recall communications.
Keep recall notification letters, proof of purchase, and inventory lists; document communications with the manufacturer.
Catalog Number: 470183. Primary UDI-DI: 04046964719400. Unit of Dose UDI-DI: 04046964715549. Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore). Quantity: 32,500 units. Recall Date: 2025-10-29. Status: ACTIVE. Brand: B. Braun Medical.
No injuries or incidents have been reported.
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