FDA issues early alert on Draeger VentStar Resus Neo hoses due to crack risk and potential ventilation failure
The FDA’s Center for Devices and Radiological Health has released an early alert about a potential high risk issue with Draeger’s VentStar Resus Neo breathing circuit hoses. The alert follows a letter from Draeger advising customers to remove certain hoses from use or sale because of possible cracks.
The affected product is the VentStar Resus Neo model MP0031004048675422358. Cracks or a detached hose could cause the hose to fall off or leak, leading to restricted ventilation or delayed therapy in critical and emergency situations.
Draeger recommends that users carefully inspect each hose before use, following the product’s Instructions for Use. Any hose showing cracks or detachment should be discarded on site; there is no requirement to return the items to the manufacturer.
The FDA will continue to monitor the situation and update this page as new information becomes available.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Breathing Circuit Issue from Draeger”
read at fda medwatch ↗
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