# China NMPA Product Recall - Heated Breathing Circuit

Source: https://www.globalkeysolutions.net/records/china_product_recall/general-medical-equipment-shanghai-co-ltd/e4d29552-ae91-4198-8d79-d3757792eb31/
Source feed: China

> China NMPA product recall for Heated Breathing Circuit by General Medical Equipment (Shanghai) Co., Ltd. published May 11, 2020. Recall level: Level 2 Recall. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its VentStar H

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its heated disposable breathing circuits.
- Company Name: General Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2020-05-11
- Product Name: Heated Breathing Circuit
- Recall Level: Level 2 Recall
- Recall Reason: This product was used by customers in conjunction with the Fisher & Paykel MR810 humidifier, a combination that is not approved. Use in conjunction with the Fisher & Paykel MR810 humidifier may result in unexplained damage to the heating wires, ignition of exhaled gases, and burns to the patient.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: General Medical Equipment (Shanghai) Co., Ltd.
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its VentStar Helix heated disposable breathing circuit, as announced by the National Medical Products Administration (NMPA) on May 11, 2020. This action follows the discovery of an overseas incident where the breathing circuit was improperly used in conjunction with a Fisher & Paykel MR810 humidifier. The company's registration certificate and instructions for use explicitly state that the VentStar Helix circuit is only approved for use with the Fisher & Paykel MR850 humidifier. The primary safety concern arises from the unapproved combination with the MR810 humidifier, which can lead to undetected damage to the heating wire. This damage poses a significant risk of igniting the breathing gas, potentially causing severe burns to patients. Dräger emphasized that it only supplies the approved VentStar Helix circuits and MR850 humidifiers to its customers. Although no similar incidents or adverse events have been reported within China, the company is proactively recalling affected products to prevent potential patient harm. Detailed information regarding specific models and batches is available in the "Medical Device Recall Event Report Form." This recall underscores the critical importance of adhering to specified product compatibility to ensure patient safety within the medical device regulatory framework.

Company: https://www.globalkeysolutions.net/companies/general-medical-equipment-shanghai-co-ltd/e78bec1e-b5e6-44db-9c62-8b77dec44ed4/