China NMPA Product Recall - Disposable pulse oximeter

Shenzhen Zhongcang Medical Technology Co., Ltd. has initiated a voluntary recall of its disposable pulse oxygen probes. This action, dated June 17, 2022, is in response to reports from users concerning insensitive data feedback provided by the devices. The affected products are identified by production batch number FD202201110060397.

Operating under the oversight of the National Medical Products Administration (NMPA), the company is undertaking a Class III recall. A Class III recall typically addresses situations where the use of a product is not likely to cause adverse health consequences. While specific inspection dates are not detailed, the recall is a proactive measure by Shenzhen Zhongcang Medical Technology Co., Ltd. following customer complaints, demonstrating the company's commitment to product safety and efficacy.

The required action involves the voluntary retrieval of all units from the specified production batch. Detailed information regarding the models, specifications, and precise scope of the recall is documented in a "Medical Device Recall Event Report Form." This structured approach ensures that all necessary steps are taken to address the reported issue and safeguard public health. This voluntary recall underscores the importance of continuous product monitoring and responsiveness to user feedback within the medical device industry to maintain quality standards.