Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning NOxBOX Ltd. NOxBOXi Nitric Oxide Delivery Device [NOXBOX-I, UDI-DI: (01)05060541640009] [HKMD No.: 150198].
According to the MHRA, the manufacturer is initiating this voluntary corrective action after becoming aware of potential malfunctions related to manifold check valves for NOxBOXi devices manufactured after May 21, 2021. The manufacturer has worked with the third-party supplier of the manifold to investigate this issue and has determined that the malfunction is due to the use of a new (updated design) check valve in the manifolds supplied by the third-party supplier. The check valves in question could misalign during device start up or during the changeover from one cylinder to another. Should a check valve malfunction occur, there is a potential risk of a leak of nitric oxide (NO) or oxygen or risk that a cylinder could change over earlier than expected or not at all.
For further information, please visit https://mhra-gov.filecamp.com/s/d/IbgzNiTcGeAcCrgF
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 May 2023