# China NMPA Product Recall - Disposable polyp removal device; disposable electric snare

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/2e83ca24-4b3f-4cbf-91c8-d468ddefd534/
Source feed: China

> China NMPA product recall for Disposable polyp removal device; disposable electric snare by Boston Scientific Corporation published January 22, 2021. Recall level: Level 2 Recall. On January 22, 2021, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trade (Shanghai) Co., Ltd. is voluntarily recalling disposable polyp removal devices; disposable polyp removal devices; disposable electric snares; disposable polyp removal devices.
- Company Name: Boston Scientific Corporation
- Publication Date: 2021-01-22
- Product Name: Disposable polyp removal device; disposable electric snare
- Recall Level: Level 2 Recall
- Recall Reason: In certain batches of disposable polyp removal devices and disposable electric snares, the single sterile packaging bag inside the product packaging box may have incomplete sealing, which may cause the sterile barrier to crack and prevent the device from maintaining a sterile state.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: On January 22, 2021, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall affecting specific batches of its disposable polyp removal devices and disposable electric snares. This action was prompted by a critical packaging defect where the single sterile packaging bag inside the product box had an incomplete seal. This flaw compromises the sterile barrier, potentially causing the devices to lose their sterile state before use. The National Medical Products Administration (NMPA) published this recall, highlighting its role in regulatory oversight for medical device safety. The affected products include various disposable polyp removal devices (Registration Certificate Nos.: 20173220892, 20173251147, 20193011633, 20193011635) and disposable electric snares (Registration Certificate No.: 20173256341). As a direct consequence, Boston Scientific is required to retrieve all implicated devices from the market to mitigate potential health risks. Further details regarding specific models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form" provided by the NMPA.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/