China NMPA Product Recall - Electric intermittent traction device

Shanghai Medicos Medical Devices Co., Ltd. initiated a voluntary Class III recall for its electric intermittent traction device, model ELKEINE V 5021, effective October 22, 2021. This action was published by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by the device's non-compliance with specific technical requirements regarding "External Marking of Equipment or Equipment Components." Issues identified included inadequate marking for fuses (accessibility, model, and nominal value) and deficiencies in the durability testing of equipment markings. Despite these deviations from testing standards, the company confirmed that the device exhibits no mechanical or functional problems and, crucially, poses no health risk to users.

This voluntary recall aligns with Article 4 of Chapter 1 of the NMPA's "Regulations on the Recall of Medical Devices" (Order No. 29), which defines defective products as those failing to meet mandatory standards or registered technical requirements. Detailed information concerning the affected product's models, specifications, and batch numbers is provided in the associated "Medical Device Recall Event Report Form."