Ventec Life Programs is recalling its Ventilator, Oxygen Concentrator, Cough Help, Suction, and Nebulizer (VOCSN) Affected person Respiration Bundle attributable to a producing challenge that causes the bonded spiral wrap to detach earlier than or throughout air flow, in accordance with a US Meals and Drug Administration recall discover.
If the spiral wrap detaches, it might probably compromise the structural integrity and performance or trigger blockage, stoppage, or leaks within the respiration circuit.
Ventec Life Programs and its product portfolio have been acquired by React Well being in 2022.
Using the affected respiration bundle could trigger severe accidents, equivalent to failure to ventilate, incomplete air flow, failure to oxygenate, and full or partial airway obstruction. The danger of damage or dying is elevated for pediatric sufferers who rely on this machine.
There have been 15 complaints concerning this challenge. There have been no reviews of accidents or dying.
The FDA has recognized this as a Class I recall, probably the most severe sort of recall.
The Ventec Life Programs VOCSN Affected person Respiration Bundle is meant to offer respiratory help for pediatric sufferers weighing no less than 11 lbs. The affected person respiration bundle could also be used at residence, the hospital, in institutional settings, or through the means of shifting sufferers to and from totally different areas of a medical facility.
The Ventec lively, oxygen affected person circuit delivers oxygen and has a respiration valve that opens and shuts.
Recalled product :
- Product names: VOCSN Affected person Respiration Bundle (Pediatric, Energetic, Oxygen, Blue)
- Product code: CBK
- Mannequin numbers: Lot # 220922, Half Quantity PRT-01013-000 (10 items/pk), Half Quantity PRT-00802-001 (1 unit)
- Manufacturing date: March 7, 2022
- Distribution dates: Dec 14, 2022, to Sept 20, 2023
- Gadgets recalled within the US: 150
- Date initiated by agency: Dec 22, 2023
Clients within the US with questions on this recall ought to contact Ventec Life Programs at 844-698-6276, Monday by way of Friday, between 8 am and 5 pm PDT.
Well being care professionals and customers could report hostile reactions or high quality issues they skilled utilizing these gadgets to MedWatch: The FDA Security Data and Opposed Occasion Reporting Program utilizing an internet kind, common mail, or fax.
