# China NMPA Product Recall - Extracorporeal circulation tubing

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-midos-medical-devices-co-ltd/e947c720-533f-4fb0-9721-dee4182fd049/
Source feed: China

> China NMPA product recall for Extracorporeal circulation tubing by Beijing Midos Medical Devices Co., Ltd. published October 29, 2018. Recall level: Level 3. Beijing Midas Medical Device Co., Ltd. initiated a voluntary Level 3 recall of its Extracorporeal Ci

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing Midos Medical Devices Co., Ltd. voluntarily recalls extracorporeal circulation tubing
- Company Name: Beijing Midos Medical Devices Co., Ltd.
- Publication Date: 2018-10-29
- Product Name: Extracorporeal circulation tubing
- Recall Level: Level 3
- Recall Reason: In 2018, an extracorporeal circulation tubing (specification: adult type, production batch number: 1803-09) sampled and tested by the Beijing Municipal Medical Device Inspection Institute failed the particulate contamination test.
- Discovering Company: Beijing Midos Medical Devices Co., Ltd.
- Manufacturing Company: Beijing Midos Medical Devices Co., Ltd.
- Summary: Beijing Midas Medical Device Co., Ltd. initiated a voluntary Level 3 recall of its Extracorporeal Circulation Tubing (adult type, production batch number: 1803-09) following a 2018 sampling inspection. The Beijing Municipal Medical Device Administration identified a failure in the product's particulate contamination item, rendering it non-compliant. This critical issue prompted the company to act under the oversight of the National Medical Products Administration (NMPA) and its local counterpart. Upon receiving the inspection results, Beijing Midas Medical Device Co., Ltd. promptly convened its technical, quality inspection, production, and sales departments. The company conducted a comprehensive investigation into the reported non-compliance and implemented corrective actions. These actions included the recall of all affected products and the destruction of any unused inventory from the identified batch. The recall affected 218 units of the product sold in China, intended for single use in patients undergoing open-heart surgery with extracorporeal circulation.

Company: https://www.globalkeysolutions.net/companies/beijing-midos-medical-devices-co-ltd/f3533493-69ea-4806-a4ec-20f6272b1776/