# China NMPA Product Recall - Anesthesia machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/8b3e1111-529e-4687-b936-a712011ad1ef/
Source feed: China

> China NMPA product recall for Anesthesia machine by Maikewei (Shanghai) Medical Equipment Co., Ltd. published December 02, 2021. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall of its ane

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling anesthesia machines.
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2021-12-02
- Product Name: Anesthesia machine
- Recall Level: Level 2 Recall
- Recall Reason: The product's accessory, the heptafluoroether vaporizer, was found to contain a yellow substance, among other issues.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall of its anesthesia machines, as announced on December 2, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by the discovery of yellow substances within the sevoflurane vaporizer, which is an accessory to the affected anesthesia machines. This issue raises concerns about the product's quality and potential patient safety. While specific inspection dates are not detailed in this recall notice, the company proactively reported the issue and commenced the recall process under the oversight of China's regulatory authorities. The regulatory framework involves the NMPA, which hosts the announcement, and the local Shanghai Municipal Drug Administration, which issued the initial recall notice. The required action for Maikewei (Shanghai) Medical Equipment Co., Ltd. is the immediate voluntary recall of all affected anesthesia machine models and batches, identified by Registration Certificate Nos. 国械注进20163542966 and 国械注进20163082966. Further details regarding specific models and batches are available in the accompanying "Medical Device Recall Event Report Form." This action aims to mitigate potential risks associated with the identified contamination.

Company: https://www.globalkeysolutions.net/companies/maikewei-shanghai-medical-equipment-co-ltd/77310e7c-a692-4918-a052-23f3348af2e9/