Ventec Life Systems is recalling its Ventilator, Oxygen Concentrator, Cough Assist, Suction, and Nebulizer (VOCSN) Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to detach before or during ventilation, according to a US Food and Drug Administration recall notice

If the spiral wrap detaches, it can compromise the structural integrity and functionality or cause blockage, stoppage, or leaks in the breathing circuit.

Ventec Life Systems and its product portfolio were acquired by React Health in 2022.

The use of the affected breathing package may cause serious injuries, such as failure to ventilate, incomplete ventilation, failure to oxygenate, and complete or partial airway obstruction. The risk of injury or death is increased for pediatric patients who depend on this device.

There have been 15 complaints regarding this issue. There have been no reports of injuries or death.

The FDA has identified this as a Class I recall, the most serious type of recall.

The Ventec Life Systems VOCSN Patient Breathing Package is intended to provide respiratory support for pediatric patients weighing at least 11 lbs. The patient breathing package may be used at home, the hospital, in institutional settings, or during the process of moving patients to and from different areas of a medical facility.

The Ventec active, oxygen patient circuit delivers oxygen and has a breathing valve that opens and shuts.

Recalled product :

  • Product names: VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue)
  • Product code: CBK
  • Model numbers: Lot # 220922, Part Number PRT-01013-000 (10 units/pk), Part Number PRT-00802-001 (1 unit)
  • Manufacturing date: March 7, 2022 
  • Distribution dates: Dec 14, 2022, to Sept 20, 2023
  • Devices recalled in the US: 150
  • Date initiated by firm: Dec 22, 2023

Customers in the US with questions about this recall should contact Ventec Life Systems at 844-698-6276, Monday through Friday, between 8 am and 5 pm PDT.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax.