Ventec Patient Breathing Package Gets Class I Recall

Ventec Life Systems has issued a product recall the FDA has deemed as Class I – but this recall is a correction, not a product removal.

The company’s Life Systems Ventilator, Oxygen concentrator, Cough Assist, Suction, and Nebulizer (VOCSN) Patient Breathing Package (Pediatric, Active, Oxygen, Blue) provides breathing support for pediatric patients weighing at least 11 pounds.

The recall is for a manufacturing issue which may cause the device’s bonded spiral wrap to detach and cause blockage, stoppage, or leaks in the breathing circuit, which could cause serious injuries, such as failure to ventilate, incomplete ventilation, failure to oxygenate, or complete or partial airway obstruction.

Read the FDA announcement for the Ventec recall here.

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