# China NMPA Product Recall - Breathing circuit; disposable heat exchanger/filter; disposable heat exchanger; filter; closed suction device; oropharyngeal airway; closed suction device

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-medical-devices-international-trading-shanghai-co-ltd/1c8fd03d-b35b-4b64-bdcf-2a5c27d7b45c/
Source feed: China

> China NMPA product recall for Breathing circuit; disposable heat exchanger/filter; disposable heat exchanger; filter; closed suction device; oropharyngeal airway; closed suction device by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. published June 07, 2021. Recall level: Level 3 Recall. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is voluntarily recalling breathing circuits, disposable heat exchangers/filters, disposable heat exchangers, filters, closed suction devices, oropharyngeal airways, and closed suction devices.
- Company Name: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-06-07
- Product Name: Breathing circuit; disposable heat exchanger/filter; disposable heat exchanger; filter; closed suction device; oropharyngeal airway; closed suction device
- Recall Level: Level 3 Recall
- Recall Reason: Potential issues with temperature/humidity deviations were discovered at the ethylene oxide sterilization site of Medtronic's former supplier, Steil Milano, resulting in missing sterilization process data for some batches of products, making it impossible to confirm product sterility.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Summary: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of multiple medical devices, including breathing circuits, disposable heat exchangers/filters, and closed suction devices. Announced on June 7, 2021, through the National Medical Products Administration (NMPA), the recall was prompted by a report from Medtronic's former supplier, Stell Milano. The report indicated a potential temperature and humidity deviation at an ethylene oxide sterilization site. While Covidien assessed that the deviation did not impact the sterility, packaging, or functionality of most products, a critical issue emerged for a specific batch where sterilization process data was missing, preventing confirmation of its sterility. Despite no reported adverse events or complaints globally, and the conclusion that the issue would not cause additional patient harm, Covidien proactively conducted the recall. This action underscores the company's commitment to maintaining product safety and regulatory compliance under the NMPA's framework. Detailed information on affected models and batches is provided in the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/covidien-medical-devices-international-trading-shanghai-co-ltd/4fdf08b9-af8e-4aed-8993-3e905e973d3b/