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 B. Braun Melsungen AG SeQuent Please Neo (Paclitaxel releasing Rapid Exchange PTCA Balloon Catheter): SeQuent Please Neo 3.5 x 25 mm [Ref. No.: 5023236; Lot No.: 22H13809]; SeQuent Please Neo 3.5 x 30 mm [Ref. No.: 5023246; Lot No.: 22H10809] [HKMD No.: 160409].
According to the MHRA, based on customer feedback, the manufacturer has become aware of incorrect labeling of at least one of the products in the batch SeQuent Please Neo 3.5 x 25 mm (REF 5023236, LOT 22H13809). A product with the balloon size 3.5 x 30 mm was in a product box marked 3.5 x 25 mm. The sterile packaging and the product itself on its adapter are marked with the correct size. The incorrect labelling has so far been confirmed for 3 products. It cannot be ruled out that other incorrectly labelled products were placed on the market. Furthermore, it cannot be excluded that there is a label with the size 3.5 x 30 mm on the sterile packaging of a 3.5 x 25 mm product. Therefore, both batches are considered affected.
For further information, please visit https://mhra-gov.filecamp.com/s/d/J2KS1oBub8kVvSuZ
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Nov 2023