# China NMPA Product Recall - Electric intermittent traction device

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-amsino-medical-devices-co-ltd/c8c5de83-44a4-4774-bc2b-9a7f3b8fa13d/
Source feed: China

> China NMPA product recall for Electric intermittent traction device by Shanghai Amsino Medical Devices Co., Ltd. published October 22, 2021. Recall level: Level 3 Recall. Shanghai Medicos Medical Devices Co., Ltd. initiated a voluntary Class III recall for its electric i

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Medicos Medical Devices Co., Ltd. is voluntarily recalling its electric intermittent traction device.
- Company Name: Shanghai Amsino Medical Devices Co., Ltd.
- Publication Date: 2021-10-22
- Product Name: Electric intermittent traction device
- Recall Level: Level 3 Recall
- Recall Reason: The product fails to meet the testing standards in the technical requirements due to "external markings of equipment or equipment components" (e.g., fuses not indicating model and nominal value, equipment markings failing durability tests), and does not comply with mandatory standards or the technical requirements of registered or filed products.
- Discovering Company: Shanghai Medicos Medical Devices Co., Ltd.
- Manufacturing Company: Shanghai Amsino Medical Devices Co., Ltd.
- Summary: 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."

Company: https://www.globalkeysolutions.net/companies/shanghai-amsino-medical-devices-co-ltd/c2b7f98f-5bac-4401-8f3b-e278676070d4/