# China NMPA Product Recall - VentStar disposable pediatric ventilation circuit

Source: https://www.globalkeysolutions.net/records/china_product_recall/draegerwerk-ag-co-kgaa/890ace93-b247-4650-a22b-1c97becf0f46/
Source feed: China

> China NMPA product recall for VentStar disposable pediatric ventilation circuit by Draegerwerk AG & Co. KGaA published August 29, 2016. Recall level: Class I Recall. Dräger Medical Equipment (Shanghai) Co., Ltd. has initiated a voluntary Level I recall for specific 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls ventilators
- Company Name: Draegerwerk AG & Co. KGaA
- Publication Date: 2016-08-29
- Product Name: VentStar disposable pediatric ventilation circuit
- Recall Level: Class I Recall
- Recall Reason: Internal testing revealed a leak in the one-way valve of the disposable pediatric ventilation circuit in the product. This leak could cause exhaled air to enter the breathing circuit, potentially leading to repeated inhalation of exhaled air and a decrease in oxygen concentration.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Draegerwerk AG & Co. KGaA
- Summary: Dräger Medical Equipment (Shanghai) Co., Ltd. has initiated a voluntary Level I recall for specific disposable pediatric ventilation circuits used with Oxylog 3000 and Oxylog 3000 Plus ventilators. This action follows internal testing that revealed a leak in the one-way valve of the VentStar Oxylog3000F(P)190 disposable pediatric ventilation circuit, part number 5704964, affecting products manufactured up to March 2016. The identified defect could allow exhaled air to re-enter the breathing circuit, potentially causing patients to repeatedly inhale exhaled air and experience a dangerous reduction in oxygen concentration. Under the regulatory framework of the National Medical Products Administration (NMPA), Dräger has implemented several required actions. These include immediately halting the distribution of all affected stock and managing its disposal. The manufacturing facility has also enhanced its quality control by implementing 100% leak testing for all newly produced circuits. Additionally, the company has issued safety notices to customers, instructing them on the proper handling and return of the recalled materials. Although no complaints or adverse events have been reported to date, this proactive recall addresses a significant potential safety risk to patients.

Company: https://www.globalkeysolutions.net/companies/draegerwerk-ag-co-kgaa/14744193-3c0e-42ad-b561-ad95278db9af/