FDA has classified Draeger's VentStar Resus Neo hose removal as a Class I recall, its most serious category. The hose is a disposable breathing circuit for infants weighing up to 22 pounds. The affected product is model MP00310, UDI 04048675422358.
The hoses can develop visible cracks or come apart at a connection. A leak or a detachment restricts ventilation or delays therapy, with desaturation, hypoxia and death among the outcomes FDA lists. Draeger reported no serious injuries or deaths when the early alert went out on September 3.
Draeger is not asking for product back. The instruction is to inspect each hose before use, following the instructions for use, and discard any hose that is cracked or has a connection that has worked loose.
An inspect-before-use remedy is the weakest control available for a part that cracks over time, and it sits with the clinician at the bedside rather than in the design. For anyone writing a risk file on a disposable circuit, this is the recall to cite when a reviewer asks why visual inspection alone is not enough.