China NMPA Product Recall - Disposable radiofrequency plasma surgical electrodes

Chengdu Meichuang Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its Disposable Radiofrequency Plasma Surgical Electrodes. This recall, publicly announced on October 21, 2019, addresses discrepancies found in the product instructions. The primary issue identified is a significant inconsistency between the information provided in the product instructions and the version approved during the product's registration.

The affected medical devices include specific models and batch numbers of the disposable radiofrequency plasma surgical electrodes. These comprise models MC201 and MC202 from batch numbers DT1703 and DT1801, as well as models MC301 and MC302 from batch number DT1707. The company holds registration certificate number 川械注准20152250027 for these devices, issued under the regulatory oversight of the National Medical Products Administration (NMPA) of China.

While specific inspection dates are not detailed in this announcement, the recall itself is a direct outcome of the identified instructional inconsistencies. The company has taken the required action of a Class III recall to address this non-compliance, indicating a situation where the probability of adverse health consequences is low but the issue warrants corrective action. Further comprehensive details regarding the specific affected products, their specifications, and batch information are documented in the "Medical Device Recall Event Report Form" submitted by the company. This action underscores the regulatory commitment to ensure that medical device information accurately reflects approved specifications.