China NMPA Product Recall - Electric cervical traction device

Henan Huazhi Biotechnology Co., Ltd. initiated a Level III voluntary recall for its Electric Cervical Traction Devices, as reported to the National Medical Products Administration (NMPA) and Henan Provincial Drug Administration on March 16, 2020. This action followed a medical device sampling inspection that revealed two main compliance issues.

First, the instruction manual for product model JLB-800C failed to specify risks associated with the disposal of waste, residue, and the equipment itself at the end of its service life. Second, the device's switch operation direction did not adhere to the national standard GB/T4205. The company clarified that the manual deficiency does not affect the device's inherent quality or safety during its intended use.

To address these violations, Henan Huazhi Biotechnology is notifying all affected customers about the identified issues and providing corrective measures. Customers are instructed to verify the switch installation; if incorrect, devices will be repaired free of charge. The company is also promptly revising the instruction manual and submitting an application for change registration to the Henan Provincial Drug Administration.