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 AG has issued a medical device safety alert concerning Coroflex ISAR Neo 2.5x19 mm [Article Number: 5028933; Lot Number: 23F03809] & Coroflex ISAR Neo 2.75x24 mm [Article Number: 5028941; Lot Number: 23F03809] [HKMD No.: 170244].
The manufacturer, based on customer complaint, has become aware of incorrect labeling of at least one of the products in the batch Coroflex ISAR Neo 2.5x19 mm (Article Number: 5028933, Lot Number: 23F03809): A product with the stent size 2.75 x 24 mm was distributed in a product box marked with the size 2.5 x 19 mm. The sterile packaging and the product itself on its adapter are marked with the correct size: The incorrect labelling has so far only been confirmed for a single product. However, it cannot be excluded that other incorrectly labelled products were placed on the market. Furthermore, it cannot be excluded that there is a label with the size 2.5 x 19 mm on the sterile packaging of a 2.75 x 24 mm 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 8 Nov 2023