NMPA Announces Multiple Medical Device Recalls Involving Johnson & Johnson, Siemens, and Others

China Economic Net Beijing, June 22nd, by reporter Hanlu Han (June 17th, the website of the National Medical Products Administration announced multiple product recall information, involving brands such as Johnson & Johnson and Siemens.)

Siemens Healthcare System Co., Ltd. reported that due to issues involving specific models and specific batches of products, there may be a risk of data loss under certain processes. The manufacturer, Siemens Healthcare GmbH, has initiated a voluntary recall of the X-ray computed tomography equipment (registration certificate number: China Medical Device Registration No. 20213060094). The recall level is classified as Level Three.

AMO (SHANGHAI) MEDICAL Devices Trading Co., Ltd. reported that due to issues involving specific models and specific batches of products, where the sterile barrier of the dust cover was compromised, Johnson & Johnson Surgical Vision, Inc. voluntarily recalled the ophthalmic phacoemulsification treatment system COMPACT INTUITIV System (registration certificate number: Guo Med Reg No. 20193160026). The recall level is Class II.

Shenzhen Zhongcang Medical Technology Co., Ltd. voluntarily recalls its disposable pulse oximeter sensors (Registration No.: Guangdong Medical Device Registration Approval 20202071629) with the production batch number FD202201110060397. The recall level is Level III.

Zimmer (Shanghai) Medical International Trading Co., Ltd. reported that due to issues involving specific models and specific batches of products, there was a problem of mistakenly labeling DVRASL plates as DVRAR or DVRASR. The manufacturer, Biomet Trauma, voluntarily recalled the locking metal osteosynthesis plate systems DVR and F3 Plate Systems (registration certificate number: Guo Med Reg No. 20183132302). The recall level is Class III.

Zimmer (Shanghai) Medical International Trade Co., Ltd. reported that due to issues involving specific models and specific batches of products, NCB self-tapping screws of different sizes were found in the packaging. The manufacturer, Zimmer GmbH Switzerland Zimmer Company, is voluntarily recalling the Locking Metal Osteosynthesis Plate and Screw System Plates and Screws System (registration certificate number: GuoXieZhuJin 20183461997). The recall level is Class III.

ConvaTec (China) Medical Supplies Co., Ltd. reported that due to issues involving specific models and specific batches of products, there were problems with stoma baseplate delamination or adhesive edge tearing. The manufacturer, ConvaTec Inc., voluntarily recalled the stoma baseplate Skin Barrier (Filing Certificate No.: GuoXieBei20200110). The recall level is Level III.

Maquet (Shanghai) Medical Equipment Co., Ltd. reported that due to issues with specific models and specific batches of products having incorrect product label information, the manufacturer InterVascular SAS has voluntarily recalled vascular prostheses (registration certificate number: Guo Med Reg No. 20183461812). The recall level is Class III.