# 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/f4c61f3e-1fc6-4b41-b07e-18e86008bafb/
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 22, 2021. Recall level: Level 2 Recall. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II r

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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: 2021-06-22
- Product Name: Breathing circuit; disposable heat exchanger/filter; disposable heat exchanger; filter; closed suction device; oropharyngeal airway; closed suction device
- Recall Level: Level 2 Recall
- Recall Reason: Former Medtronic supplier Steril Milano reported a potential issue related to temperature/humidity deviations at its ethylene oxide sterilization site. Due to missing sterilization process data for specific batches, the sterility of these batches could not be confirmed, prompting a voluntary recall.
- 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 II recall on June 22, 2021, affecting several medical devices, including breathing circuits, disposable heat exchangers/filters, filters, closed suction devices, and oropharyngeal airways. This action was prompted by a report from their former supplier, Stellil Milano, concerning temperature and humidity deviations at its ethylene oxide sterilization facility. While an internal assessment determined these deviations did not compromise the sterility or functionality of most products, a critical issue arose with a specific production batch. For this batch, essential sterilization process data was missing, making it impossible to confirm its sterility. Despite the absence of global complaints or adverse events related to this specific problem, Covidien chose to conduct the recall as a precautionary measure. The recall process is overseen within the regulatory framework of the National Medical Products Administration (NMPA) in China. Detailed information regarding the models, specifications, and affected batches is documented in the accompanying 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/