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 States Food and Drug Administration (FDA) has posted a medical device safety alert concerning SenTec AG Membrane Changer Single-Use, Membrane Changer Reloadable, Membrane Changer Insert [REF MC: 230441, 230224, 230209, 230191, 230185, 230167, 230165, 230146, 230125, 230016, 225261, 225226, 225183, 225173, 225149, 225147, 225126, 225122, 225088, 225073, 225063, 225006; REF MC-R: 230461, 230329, 230351, 230235, 230083, 230053, 230043, 230008, 230005, 225253, 225221; REF MC-I: 230372, 230339, 230336, 230229, 230206, 230132, 230117, 230051, 230044, 230012, 225299, 225298, 225280, 225255, 225218, 225216, 225190, 225185, 225184, 225175, 225120, 225091, 225089, 225064, 225058, 225033, 225023, 221064, 221056; UDI-DI numbers: 07640121880933, 17640121880930, 07640121880087, 17640121880084, 27640121880081, 07640121880506, 17640121880503] [HKMD No.: 200487].
According to the FDA, during rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92833
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Sep 2023