Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap
Please be aware, this recall is a correction, not a product removal.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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: December 14, 2022 to September 20, 2023
- Devices Recalled in the U.S.: 150
- Date Initiated by Firm: December 22, 2023
Device Use
The Ventec Life Systems Ventilator, Oxygen concentrator, Cough Assist, Suction, and Nebulizer (VOCSN) Patient Breathing Package (Pediatric, Active, Oxygen, Blue) 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.
Reason for Recall
Ventec Life Systems is recalling its VOCSN Patient Breathing Package due to a manufacturing issue which causes the bonded spiral wrap to detach before or during ventilation. If the spiral wrap detaches, it can compromise the structural integrity, functionality, or cause blockage, stoppage, or leaks in the breathing circuit.
The use of the affected breathing package may cause serious injuries, such as failure to ventilate, incomplete ventilation, failure to oxygenate, 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.
Who May be Affected
- Pediatric patients who use the VOCSN Patient Breathing Package
What to Do
On January 10, 2024, Ventec Life Systems sent all affected customers an Urgent Medical Device Recall Notification.
The notification requested customers to:
- Stop use of the affected Patient Breathing Package and replace it with a non-affected product.
- Inspect current stock and quarantine any unused affected products to prevent its use.
- Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator.
Contact Information
Customers in the U.S. with questions about this recall should contact Ventec Life Systems at 844-698-6276, Monday through Friday, between 8:00 a.m. to 5:00 p.m. PDT.
Additional Resources
How do I report a problem?
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.