Aerogen flags incorrect ENFit syringes in some Solo Continuous Nebulization Tube Sets
The Dutch inspectorate IGJ has published a manufacturer field safety notice covering the Aerogen Solo Continuous Nebulization Tube Set, citing incorrect enteral syringes in some products.
The Dutch healthcare inspectorate IGJ has posted a manufacturer warning from Aerogen Ltd on the Aerogen Solo Continuous Nebulization Tube Set (CNTS). The notice concerns a syringe intended for use with the set to deliver medication to the Aerogen continuous nebulizer.
According to the IGJ page, the notice explains that some products contain incorrect ENFit enteral syringes. It also says which stock is affected and sets out the measures required. The IGJ summary does not give lot numbers or the specific actions, which are in the attached document.
The manufacturer's field safety notice (FSN) is dated 28 October 2026. The PDF on the IGJ site is labelled 10 November 2026 and runs to seven pages.
IGJ describes the item as a manufacturer warning. Manufacturers must monitor their devices after they reach the market and take action where users are at risk. They tell users and the inspectorate about that action through an FSN.
What it means for your team
- Hospitals and distributors in the Netherlands should open the full FSN to check affected stock and the required actions, as the IGJ summary does not list them.
- Quality and vigilance teams should check inventories of the Aerogen Solo CNTS against the affected stock described in the notice.
- Regulatory teams should note the gap between the FSN date (28 October 2026) and the PDF label (10 November 2026) when logging the notice.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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