NMPA Issues Class II/III Medical Device Recalls for Roche, Smith & Nephew, Bard, and Others

On October 17, the official website of the National Medical Products Administration released seven pieces of information on voluntary recalls of medical device products. The specific information is as follows:

Smith&Nephew Medical Products International Trade (Shanghai) Co., Ltd. Report, due to product packaging issues, the manufacturer, Smith & Nephew, Inc., based in the United States, has taken action on its production.Total Knee System-Oxinium Femoral Implant（China Medical Device Registration No. 20153132542) Voluntary recall. Recall level isLevel 2 Recall。

Bard Medical Technology (Shanghai) Co., Ltd. Report, due to specific batches of MARQUEE® Disposable Biopsy Needle with Integrated Guide inWhen the trigger is pressed, the inner needle rod is ejected. The manufacturer, Bard Peripheral Vascular, Inc., produced it.Disposable Integrated Biopsy Needle BARD®MARQUEE® Disposable Core Biopsy Instrument（China Medical Device Registration No. 20202140405）、BARD® MARQUEE® Disposable Core Biopsy Instrument Kit（China Medical Device Registration No. 20202140429) Voluntary recall. Recall level isLevel 2 Recall。

Roche Diagnostics (Shanghai) Co., Ltd. ReportDue to the discovery that the %Quick value of the prothrombin time test card with batch number 77409113 exceeded the product specification (falsely low), the manufacturer Roche Diagnostics GmbH has taken action regarding its production.Prothrombin Time Test Card (Electrochemical Method)（China Medical Device Registration No. 20202400275) Voluntary recall. Recall level isLevel 2 Recall。

Cook (China) Medical Trading Co., Ltd. ReportDue to the discovery that the product label displayed an incorrect expiration date, the manufacturer Cook Incorporated has initiated a recall of its products.Micro Wire Approach CTO Micro Wire Guide（China Medical Device Registration No. 20183031934) Voluntary recall. Recall level isLevel 2 Recall。

Carl Zeiss Shanghai Co., Ltd. Report, Due to the fact that the excimer laser systems MEL80/MEL90 sold in Japan are equipped with functions PRK (Photorefractive Keratectomy) and PTK (Phototherapeutic Keratectomy), which have not yet been approved in Japan, the manufacturer Carl Zeiss Meditec AG (Germany) has taken action regarding its production.Excimer Laser System（China Medical Device Registration No. 20153163346, China Medical Device Registration No. 20153243346) Voluntary recall. Recall level isLevel 2 Recall。

Olympus Trading (Shanghai) Co., Ltd. reported,Due to the reason that ultraviolet radiation may cause the tip of the ureteral sheath dilator to break, the manufacturer Gyrus ACMI, Inc. has taken action regarding its production.Ureteral Access Sheath（China Medical Device Registration No. 20162020704) Voluntary recall. Recall level isLevel 2 Recall。

Maquet (Shanghai) Medical Equipment Co., Ltd. reported,Due to inconsistent labels on the inner and outer packaging of a certain batch of products, the manufacturer Datascope Corp. has taken action regarding its production.MEGA Intra-Aortic Balloon Catheters and Accessories（China Medical Device Registration No. 20183031789) Voluntary recall. Recall level isLevel 3 Recall。