# China NMPA Product Recall - Breathing tubing for anesthesia machines and ventilators

Source: https://www.globalkeysolutions.net/records/china_product_recall/hangzhou-dekaili-medical-equipment-co-ltd/9d1e5288-84fb-4688-a74a-3876d171da7d/
Source feed: China

> China NMPA product recall for Breathing tubing for anesthesia machines and ventilators by Hangzhou Dekaili Medical Equipment Co., Ltd. published September 30, 2017. Recall level: Level 3 Recall. Hangzhou Jingling Medical Device Co., Ltd. initiated a voluntary Level III recall of its breathing t

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hangzhou Jingling Medical Devices Co., Ltd. is voluntarily recalling breathing tubing for anesthesia machines and ventilators.
- Company Name: Hangzhou Dekaili Medical Equipment Co., Ltd.
- Publication Date: 2017-09-30
- Product Name: Breathing tubing for anesthesia machines and ventilators
- Recall Level: Level 3 Recall
- Recall Reason: There appears to be glue overflowing during the bonding of the product interface to the tube blank, which may affect the airflow resistance performance of the breathing tubing.
- Discovering Company: Hangzhou Jingling Medical Equipment Co., Ltd.
- Manufacturing Company: Hangzhou Dekaili Medical Equipment Co., Ltd.
- Summary: Hangzhou Jingling Medical Device Co., Ltd. initiated a voluntary Level III recall of its breathing tubing for anesthesia machines and ventilators, as reported on September 18, 2017, under the oversight of the National Medical Products Administration (NMPA). The recall was triggered by a manufacturing concern involving suspected glue overflow during the bonding of the product interface to the tubing preform. This defect could adversely affect the airflow resistance performance of the breathing tubing, potentially impacting patient safety. The recall specifically targets product model HX-01G 1.6m, impacting batches 44511704 and 44511706, with 750 sets produced and 704 sets sold in China. As part of the required corrective actions, the company must immediately issue a notice to cease the use and sale of the identified products, and recall all affected units that have been sold but remain unused. Additionally, Hangzhou Jingling Medical Device Co., Ltd. is mandated to improve its performance testing methods for airflow resistance and retest all returned products to ensure compliance and address the quality issue effectively.

Company: https://www.globalkeysolutions.net/companies/hangzhou-dekaili-medical-equipment-co-ltd/05ae3d6f-dd96-40f7-b78a-f6e3c1da6bd1/