VOCSN
Ventec Life Systems, Inc. · Model V+O+C+S+N+Pro, Japanese · UDI-DI 00855573007204
Description
V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-10 | Medline Industries, LP | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inad |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-01-09 | Kung Shin Plastics Co. Ltd. | The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable |
| 2025-01-09 | Kung Shin Plastics Co. Ltd. | The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-07-18 | Smiths Medical ASD Inc. | Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product |
| 2023-01-05 | S & MOHR AMERICA, S.A. DE C.V. | Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027" |
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