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 B. Braun Melsungen AG Stimuplex A (30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251); Stimuplex A (30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260); Stimuplex A (30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278); Stimuplex A (30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502) [HKMD number: 150253].
According to the FDA, the devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94637
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Jun 2024