China NMPA Product Recall - Patient monitor accessory - IBP cable (B. Braun connector)

Shenzhen Mindray Medical International Co., Ltd. has initiated a voluntary Class III recall of specific patient monitor accessories – IBP cables (B.Braun interface). Published on August 2, 2022, by the National Medical Products Administration (NMPA) and originating from the Guangdong Provincial Drug Administration, this action addresses a significant product issue. The main issue identified stems from random sampling, which revealed that models 01.57.471835012, 01.57.471835013, and 01.57.471836013 of the IBP cable can produce abnormally high invasive blood pressure readings when used in conjunction with a B.Braun disposable blood pressure sensor. This defect poses a risk of inaccurate medical measurements, potentially leading to incorrect clinical decisions and patient harm. Operating under the oversight of the NMPA, the company's required action is a comprehensive voluntary recall of all affected product batches and models. This measure is intended to prevent any resulting injury incidents by removing the non-conforming products from circulation. Detailed information regarding the affected products, including registration certificate numbers, specifications, and batch identifiers, is made available in the "Medical Device Recall Event Report Form."