ICU Medical Inc‘s ICUI subsidiary, Smiths Medical, initiated a recall Friday of its paraPAC plus P300 and P310 ventilators due to faulty parts.

According to the FDA, there’s a possibility that the patient outlet connector may loosen or detach, impacting active ventilation. If this happens, it could cause serious adverse health consequences, including not enough ventilation (hypoventilation), not enough oxygen (hypoxia), slowed heartbeat (bradycardia), low blood pressure (hypotension), a sudden stop of the lungs (respiratory arrest), and death.

There has been one reported injury. There has been one report of death.

Smiths Medical PneuPAC paraPAC Plus P300 and P310 Ventilators are gas-powered emergencies and transport portable ventilators, including in vehicles such as airplanes and helicopters.

They are suitable for emergencies at accident scenes and transports between hospitals or within a hospital or medical facility. These ventilators are intended to provide ventilatory support for adults, children, and infants.

The paraPAC Plus devices also provide free-flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients. They can also be used in emergency situations to provide ventilatory support for CPR resuscitation.

Earlier this week, Smiths Medical initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes due. A manufacturing defect caused the securement flange on the device to tear. There have been 35 reported injuries and two reported deaths.

Price Action: ICU Medical stock is down 1.56% at $178.44 at last check Friday.

Read Next: