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FDA (Device enforcement)Recalled 2025-10-29class ii

B Braun Medical Inc: Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. L

Hazard

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Details from the source

Reason for recall: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 23,650 units Lot/code info: 1. Catalog Number: 490291; Primary UDI-DI: 04046964716768; Unit of Dose UDI-DI: 04046964716751.

UPC codes

04046964716768, 04046964716751

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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