# China NMPA Product Recall - Non-invasive ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/respironics-medical-products-shenzhen-co-ltd/22be65c0-8f43-49f1-b855-22a7aedc44df/
Source feed: China

> China NMPA product recall for Non-invasive ventilator by Respironics Medical Products (Shenzhen) Co., Ltd. published June 17, 2021. Recall level: Level 2 Recall. Respironics Medical Products (Shenzhen) Co., Ltd. has initiated a voluntary Level II recall of its n

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Respironics Medical Products (Shenzhen) Co., Ltd. voluntarily recalls non-invasive ventilators.
- Company Name: Respironics Medical Products (Shenzhen) Co., Ltd.
- Publication Date: 2021-06-17
- Product Name: Non-invasive ventilator
- Recall Level: Level 2 Recall
- Recall Reason: The polyester-based polyurethane (PE-PUR) sound-absorbing foam used in non-invasive ventilators may have two potential problems: 1. PE-PUR foam can pulverize under certain conditions, and these particles may enter the air passage of the device and be ingested or inhaled by the user. 2. PE-PUR foam may release certain organic compounds under certain conditions.
- Discovering Company: Respironics Medical Products (Shenzhen) Co., Ltd.
- Manufacturing Company: Respironics Medical Products (Shenzhen) Co., Ltd.
- Summary: Respironics Medical Products (Shenzhen) Co., Ltd. has initiated a voluntary Level II recall of its non-invasive ventilators, as reported by the National Medical Products Administration (NMPA) on June 17, 2021. The recall is driven by significant safety concerns related to the polyester polyurethane (PE-PUR) sound-absorbing foam used in these devices. The company identified two main issues: the foam's potential to release particles that could enter the device's air passage and be ingested or inhaled by users, and its capacity to emit certain organic compounds under specific conditions. This action falls under the regulatory oversight of the NMPA, which manages medical product safety in China. The required action involves the prompt removal of affected non-invasive ventilators from circulation. Detailed information regarding the specific models, specifications, and batches involved in this recall is contained within a "Medical Device Recall Event Report Form." This proactive measure aims to protect public health by addressing device material degradation and potential user exposure to harmful substances.

Company: https://www.globalkeysolutions.net/companies/respironics-medical-products-shenzhen-co-ltd/3bb8ef37-16a8-41d5-86a7-b5a04a731575/