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.
Medical device manufacturer, B. Braun Melsungen, has issued a medical device safety alert concerning B. Braun Melsungen AG Sequent Neo 2.0 x 10mm and 2.5 x 20mm [Article Number: 5021713D, 5021735D; Lot Number: 22F29844, 22F30844] [HKMD No.: 150204].
The manufacturer has become aware of incorrect labeling of at least one of the products from the batch SeQuent Neo 2.0 x 10 mm. A product with the balloon size 2.5 x 20mm was in a product box marked 2.0 x 10mm. The sterile packaging and the product itself on its adapter are marked with the correct size.
According to the manufacturer, the incorrect labeling has so far been confirmed for one product. However, it cannot be excluded that other incorrectly labeled products were placed on the market. Furthermore, it cannot be excluded that there is a label with the size 2.0 x 10mm on the sterile packaging of a 2.5 x 20mm product. Therefore, both batches are considered affected.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Nov 2023