NMPA Announces Class II Recalls of Medical Devices by Nihon Kohden, Accelerate Diagnostics, and B. Braun Surgical SA

On October 8, the National Medical Products Administration (NMPA) issued an announcement, notifying that three medical device companies—Nihon Kohden Corporation, Inpeo S.A., and B.Braun Surgical SA—have voluntarily recalled some of their non-compliant products. These include patient monitors, sample processing systems, and absorbable surgical sutures with needles.

The specific situation is as follows:

Nihon Kohden Corporation Initiates Voluntary Recall of Bedside Monitor Patient Monitors

Shanghai Nihon Kohden Medical Electronics Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is a problem where a particular version of the embedded software cannot correctly recognize information sent from the host device used in combination. The manufacturer, Nihon Kohden Corporation, has initiated a voluntary recall of the bedside patient monitor ベッドサイドモニタ (registration certificate number: GuoXieZhuJin 20173070840).Recall level is Level 2.

Attachment:Medical Device Recall Incident Report Form

Accelerator a3600 Sample Processing System Proactively Recalled by Veripoc Group Switzerland Headquarters

Abbott Trading (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is a possibility that the interface module may associate results with incorrect sample IDs. The manufacturer, Inpeo Group Switzerland Headquarters, has initiated a voluntary recall of the ACCELERATOR a3600 Sample Processing System (registration number: GJXieBei20161009).Recall Level: Class II.

Attachment:Medical Device Recall Incident Report Form

B.Braun Surgical SA Voluntarily Recalls Absorbable Surgical Suture with Needle

B. Braun Medical (Shanghai) International Trade Co., Ltd. reported that due to issues involving specific models and specific batches of products, which failed to meet degradation test results according to product standards, the manufacturer B.Braun Surgical SA has initiated a voluntary recall of Absorbable Surgical Suture with needles (Registration Certificate No.: Guo Med Reg In 20163654884).Recall level is Level 2.

Attachment:Medical Device Recall Incident Report Form