Smiths Medical, a subsidiary of ICU Medical Inc., has issued a recall for its paraPAC plus P300 and P310 ventilators. The recall comes after the company discovered a potential safety issue with the patient outlet connector. According to the FDA, there is a risk that the connector could loosen or detach, potentially impacting active ventilation. This could lead to serious consequences for patients, including:
* Hypoventilation (not enough ventilation)
* Hypoxia (not enough oxygen)
* Bradycardia (slowed heartbeat)
* Hypotension (low blood pressure)
* Respiratory arrest (sudden stop of the lungs)
* Death
The company has reported one death and one injury related to this issue.
The paraPAC Plus P300 and P310 ventilators are gas-powered emergency and transport ventilators, designed for use in a variety of settings, including ambulances, airplanes, and hospitals. These devices are used to provide ventilatory support for adults, children, and infants in emergency situations. They can also be used for CPR resuscitation and for providing free-flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients.
This recall follows a previous recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes due to a manufacturing defect. That recall led to 35 reported injuries and two deaths.
ICU Medical stock is down 1.56% at $178.44 at last check Friday.
